Trial Outcomes & Findings for A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects (NCT NCT00730327)

Last Updated: 2015-11-06

Results Overview

The first co-primary effectiveness measure, was mean percent excess weight loss (% EWL) at 9 months (3 months after the balloon was removed for the BIB group). Percent EWL was calculated using the 1983 Met Life tables for determination of ideal body weight, per the protocol-defined primary effectiveness endpoint. Percent EWL was calculated as %EWL= (weight loss divided by excess weight)\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight.

Recruitment status

COMPLETED

Study phase

Target enrollment

448 participants

Primary outcome timeframe

9 months

Results posted on

2015-11-06

Participant Flow

Patients were enrolled at 15 investigational sites across the US, between 6/20/2008 and 10/10/2010. Patients were either enrolled as run-in subjects (mentored cases which were enrolled prior to randomized subjects in order for physicians to gain experience with placing and removing the device) or as subjects for randomization.

448 subjects were enrolled (defined as signing the informed consent), 44 of which were run-in subjects. Prior to randomization, 131 subjects were screen failures. 273 subjects were randomized to the BIB (137) and control groups (136). 12 BIB and 6 control subjects discontinued prior to treatment. 125 BIB and 130 control subjects began treatment.

Participant milestones

Participant milestones
Measure	BIB® Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Overall Study STARTED	125	130
Overall Study Completed Week 26	125	99
Overall Study COMPLETED	98	93
Overall Study NOT COMPLETED	27	37

Reasons for withdrawal

Reasons for withdrawal
Measure	BIB® Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Overall Study Lost to Follow-up	14	16
Overall Study Adverse Event	8	1
Overall Study Withdrawal by Subject	3	13
Overall Study Subject withdrew (reason not specified)	2	7

Baseline Characteristics

A Study of BioEnterics® Intragastric Balloon (BIB®) System to Assist in the Weight Management of Obese Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BIB® n=125 Participants Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=130 Participants Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Total n=255 Participants Total of all reporting groups
Age, Customized 18-19 years	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Age, Customized 20-29 years	21 participants n=5 Participants	18 participants n=7 Participants	39 participants n=5 Participants
Age, Customized 30-39 years	49 participants n=5 Participants	37 participants n=7 Participants	86 participants n=5 Participants
Age, Customized 40-49 years	31 participants n=5 Participants	54 participants n=7 Participants	85 participants n=5 Participants
Age, Customized 50-59 years	22 participants n=5 Participants	16 participants n=7 Participants	38 participants n=5 Participants
Age, Customized 60 years & over	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	117 Participants n=7 Participants	229 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	101 participants n=5 Participants	106 participants n=7 Participants	207 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants
Race/Ethnicity, Customized Black (not of Hispanic origin)	14 participants n=5 Participants	15 participants n=7 Participants	29 participants n=5 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
BMI BMI <30	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
BMI BMI ≥30 and <35	63 participants n=5 Participants	57 participants n=7 Participants	120 participants n=5 Participants
BMI BMI ≥35 and ≤40	56 participants n=5 Participants	70 participants n=7 Participants	126 participants n=5 Participants
BMI BMI >40	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Number of Years Obese < 5 years obese	20 participants n=5 Participants	22 participants n=7 Participants	42 participants n=5 Participants
Number of Years Obese 5-9 years obese	35 participants n=5 Participants	26 participants n=7 Participants	61 participants n=5 Participants
Number of Years Obese 10-19 years obese	38 participants n=5 Participants	51 participants n=7 Participants	89 participants n=5 Participants
Number of Years Obese 20-29 years obese	18 participants n=5 Participants	19 participants n=7 Participants	37 participants n=5 Participants
Number of Years Obese 30-39 years obese	10 participants n=5 Participants	6 participants n=7 Participants	16 participants n=5 Participants
Number of Years Obese 40-49 years obese	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Number of Years Obese 50 years obese & over	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Number of Years Obese Unknown	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Randomized participants in the intent-to-treat (ITT) population who completed the 39 week (month 9) follow-up visit (with last observed carried forward).

Outcome measures

Outcome measures
Measure	BIB® n=91 Participants Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=95 Participants Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Mean Percent Excess Weight Loss (%EWL)	26.52 percentage of EWL Standard Deviation 20.70	9.67 percentage of EWL Standard Deviation 15.11

PRIMARY outcome

Timeframe: 9 months

Population: Randomized participants in the ITT population who completed the 39 week (9 month) follow-up visit (with last observation carried forward).

The second co-primary effectiveness measure was the percentage of BIB treated participants with significantly greater weight loss than the control group at 9 months. Significantly greater weight loss was defined as ≥ 15% EWL over the mean %EWL of the control group. %EWL= (weight loss divided by excess weight) \* 100, where Weight loss = Baseline weight - selected follow-up weight and Excess weight = Baseline weight - ideal weight. Ideal weight was determined by using the 1983 Metropolitan Life Height and Weight Table.

Outcome measures

Outcome measures
Measure	BIB® n=91 Participants Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group 15% EWL over the control group mean	45.60 percentage of BIB participants Interval 36.67 to 54.75	—
Percentage of BIB Treated Participants With Significantly Greater Weight Loss Than the Control Group 25% EWL over the control group mean	32.8 percentage of BIB participants Interval 24.67 to 41.77	—

SECONDARY outcome

Timeframe: Baseline, Week 26, Week 39, Week 52

Population: Randomized participants in the ITT population that provided data at that timepoint. n=number of participants who provided lab data at that visit (number of participants varied as not all participants provided all lab data at each visit).

The percent of participants with a comorbid condition (type 2 diabetes, hypertension, or dyslipidemia) at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12 months) as compared to baseline. Comorbid conditions were measured and diagnosed by lab tests and vital signs. Type 2 Diabetes was diagnosed if participants' had a Fasting Plasma Glucose (FPG) ≥126 mg/dL, or symptoms of diabetes plus casual plasma glucose concentration ≥200 mg/dL. Hypertension was diagnosed if participants' blood pressure measured ≥140 mmHg systolic or ≥90 mmHg diastolic. Dyslipidemia was diagnosed if participants' labs measured: LDL ≥160 mg/dL, Total Cholesterol ≥240 mg/dL, Serum Triglycerides ≥200 mg/DL, HDL \<50 mg/dL (male) or \<40 mg/dL (female).

Outcome measures

Outcome measures
Measure	BIB® n=125 Participants Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=130 Participants Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Percent of Participants With Comorbid Conditions Diabetes-Baseline (BIB n=124, Control n=130)	7.3 percentage of participants	6.2 percentage of participants
Percent of Participants With Comorbid Conditions Diabetes-Week 26 (BIB n=100, Control n=94)	3.0 percentage of participants	4.3 percentage of participants
Percent of Participants With Comorbid Conditions Diabetes-Week 39 (BIB n=102, Control n=94)	4.9 percentage of participants	3.2 percentage of participants
Percent of Participants With Comorbid Conditions Diabetes-Week 52 (BIB n=95, Control n=94)	3.2 percentage of participants	5.3 percentage of participants
Percent of Participants With Comorbid Conditions Hypertension-Baseline (BIB n=125, Control n=130)	26.4 percentage of participants	28.5 percentage of participants
Percent of Participants With Comorbid Conditions Hypertension-Week 26 (BIB n=124, Control n=91)	17.7 percentage of participants	19.8 percentage of participants
Percent of Participants With Comorbid Conditions Hypertension-Week 39 (BIB n=91, Control n=95)	15.4 percentage of participants	21.1 percentage of participants
Percent of Participants With Comorbid Conditions Hypertension-Week 52 (BIB n=98, Control n=92)	11.2 percentage of participants	22.8 percentage of participants
Percent of Participants With Comorbid Conditions Dyslipidemia-Baseline (BIB n=125, Control n=130)	39.2 percentage of participants	30.0 percentage of participants
Percent of Participants With Comorbid Conditions Dyslipidemia-Week 26 (BIB n=102, Control n=94)	31.4 percentage of participants	27.7 percentage of participants
Percent of Participants With Comorbid Conditions Dyslipidemia-Week 39 (BIB n=102, Control n=95)	28.4 percentage of participants	28.4 percentage of participants
Percent of Participants With Comorbid Conditions Dyslipidemia-Week 52 (BIB n=96, Control n=94)	30.2 percentage of participants	26.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 39

Population: Randomized participants in the ITT population that provided data at each timepoint. n = number of participants (number of participants varied as not all participants provided data on all questionnaire items at both timepoints).

The change in quality of life from baseline to 9 months was measured by the Short Form 36 (SF-36) questionnaire. The SF-36 health survey consists of 36 questions that evaluate 8 discrete domains: Physical Functioning (Physical Func), Social Functioning (Social Func), Bodily Pain, General Health Perceptions (General Health), Vitality, Role limitations due to emotional problems (Role-Emotional), Role limitations due to physical health (Role Physical), and Mental Health. The score for each domain ranges from 0 (poorest health status) to 100 (best health status). The BIB group's mean scores for each SF-36 domain at baseline and week 39 were compared to the control group's mean scores.

Outcome measures

Outcome measures
Measure	BIB® n=123 Participants Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=130 Participants Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Change in Quality of Life (SF-36) Physical Func-Baseline (BIB n=122, Control n=130)	71.4 units on a scale Standard Deviation 22.09	73.7 units on a scale Standard Deviation 21.14
Change in Quality of Life (SF-36) Physical Func-Week 39 (BIB n=98, Control n=92)	90.0 units on a scale Standard Deviation 14.26	85.4 units on a scale Standard Deviation 15.5
Change in Quality of Life (SF-36) Role Physical-Baseline (BIB n=123, Control n=130)	78.5 units on a scale Standard Deviation 21.59	80.3 units on a scale Standard Deviation 23.07
Change in Quality of Life (SF-36) Role Physical-Week 39 (BIB n=98, Control n=93)	93.0 units on a scale Standard Deviation 13.56	85.6 units on a scale Standard Deviation 20.89
Change in Quality of Life (SF-36) Bodily Pain-Baseline (BIB n=123, Control n=130)	72.8 units on a scale Standard Deviation 21.88	75.4 units on a scale Standard Deviation 22.34
Change in Quality of Life (SF-36) Bodily Pain-Week 39 (BIB n=99, Control n=93)	84.9 units on a scale Standard Deviation 18.84	76.2 units on a scale Standard Deviation 23.91
Change in Quality of Life (SF-36) General Health-Baseline (BIB n=123, Control n=128)	61.9 units on a scale Standard Deviation 20.22	63.4 units on a scale Standard Deviation 20.11
Change in Quality of Life (SF-36) General Health-Week 39 (BIB n=99, Control n=93)	79.1 units on a scale Standard Deviation 16.53	68.6 units on a scale Standard Deviation 20.67
Change in Quality of Life (SF-36) Vitality-Baseline (BIB n=123, Control n=130)	52.7 units on a scale Standard Deviation 18.19	53.0 units on a scale Standard Deviation 19.11
Change in Quality of Life (SF-36) Vitality-Week 39 (BIB n=99, Control n=93)	67.6 units on a scale Standard Deviation 17.74	58.3 units on a scale Standard Deviation 21.08
Change in Quality of Life (SF-36) Social Func-Baseline (BIB n=123, Control n=130)	80.5 units on a scale Standard Deviation 21.89	80.8 units on a scale Standard Deviation 23.30
Change in Quality of Life (SF-36) Social Func-Week 39 (BIB n=99, Control n=93)	92.6 units on a scale Standard Deviation 13.35	83.3 units on a scale Standard Deviation 22.14
Change in Quality of Life (SF-36) Role Emotional-Baseline (BIB n=123, Control n=130)	84.0 units on a scale Standard Deviation 22.65	84.6 units on a scale Standard Deviation 20.81
Change in Quality of Life (SF-36) Role Emotional-Week 39 (BIB n=98, Control n=93)	92.2 units on a scale Standard Deviation 15.55	86.8 units on a scale Standard Deviation 19.75
Change in Quality of Life (SF-36) Mental Health-Baseline (BIB n=123, Control n=130)	74.0 units on a scale Standard Deviation 17.91	73.7 units on a scale Standard Deviation 16.60
Change in Quality of Life (SF-36) Mental Health-Week 39 (BIB n=99, Control n=93)	80.1 units on a scale Standard Deviation 15.82	72.5 units on a scale Standard Deviation 18.09

SECONDARY outcome

Timeframe: Baseline, Week 26, Week 39, Week 52

The change in quality of life from baseline to 12 months was measured by the Impact of Weight on Quality of Life - Lite (IWQOL-Lite) questionnaire. IWQOL-Lite consists of 31 scale items to assess obesity-related quality of life, and total score ranges from 0 (worst) to 100 (best). The BIB group's mean IWQOL-Lite score at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months) and Week 52 (12 months) were compared to the control group's mean scores at the same timepoints.

Outcome measures

Outcome measures
Measure	BIB® n=121 Participants Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=127 Participants Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Change in Quality of Life (IWQOL-Lite) Baseline (BIB n=121, Control n=127)	68.40 units on a scale Standard Deviation 18.733	68.55 units on a scale Standard Deviation 17.356
Change in Quality of Life (IWQOL-Lite) Week 26 (BIB n=103, Control n=94)	84.64 units on a scale Standard Deviation 12.888	76.67 units on a scale Standard Deviation 16.472
Change in Quality of Life (IWQOL-Lite) Week 39 (BIB n=99, Control n=93)	85.78 units on a scale Standard Deviation 14.411	78.58 units on a scale Standard Deviation 16.833
Change in Quality of Life (IWQOL-Lite) Week 52 (BIB n=97, Control n=94)	85.79 units on a scale Standard Deviation 15.424	79.85 units on a scale Standard Deviation 16.189

SECONDARY outcome

Timeframe: Baseline, Week 26, Week 39, Week 52

Population: Randomized participants in the ITT population that provided data at each visit. n=the number of participants (number of participants varies as not all participants completed the questionnaire at each visit)

Participants were assessed for depression using the Beck Depression Inventory II (BDI-II) questionnaire. The BDI-II consists of 21 questions to measure depressive symptoms and severity. The overall score ranges from 0-63, where higher total scores indicate more severe depressive symptoms. A total score of 0-13 is considered a minimal range, 14-19 is mild, 20-28 is moderate and 29-63 is interpreted as severe depressive symptoms. The mean BDI-II score for the BIB and control groups were assessed at baseline and at key timepoints: Week 26 (month 6, balloon removal for BIB group), Week 39 (month 9), and Week 52 (month 12, study completion).

Outcome measures

Outcome measures
Measure	BIB® n=124 Participants Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=130 Participants Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Change in Participant Depression (Beck Depression Inventory II) Baseline (BIB n=124, Control n=130)	7.7 units on a scale Standard Deviation 7.92	8.4 units on a scale Standard Deviation 7.79
Change in Participant Depression (Beck Depression Inventory II) Week 26 (BIB n=104, Control n=95)	3.7 units on a scale Standard Deviation 4.83	7.0 units on a scale Standard Deviation 8.30
Change in Participant Depression (Beck Depression Inventory II) Week 39 (BIB n=99, Control n=93)	3.6 units on a scale Standard Deviation 5.12	6.3 units on a scale Standard Deviation 6.68
Change in Participant Depression (Beck Depression Inventory II) Week 52 (BIB n=97, Control n=95)	3.9 units on a scale Standard Deviation 6.42	5.7 units on a scale Standard Deviation 7.30

POST_HOC outcome

Timeframe: Baseline, Week 26, Week 39, Week 52

Population: Randomized participants in the ITT population who provided weight data at that visit. n=number of participants (number of participants varies as not all participants provided data at each timepoint).

Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine the change in participant's Body Mass Index (BMI) at key timepoints throughout the study. The mean BMI for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).

Outcome measures

Outcome measures
Measure	BIB® n=125 Participants Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=130 Participants Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Change in BMI Baseline (BIB n=125, Control n=130)	35.20 kg/m² Standard Deviation 3.165	35.43 kg/m² Standard Deviation 2.650
Change in BMI Week 26 (BIB n=117, Control n=91)	31.43 kg/m² Standard Deviation 3.762	33.61 kg/m² Standard Deviation 3.253
Change in BMI Week 39 (BIB n=91, Control n=95)	31.85 kg/m² Standard Deviation 4.035	33.83 kg/m² Standard Deviation 3.300
Change in BMI Week 52 (BIB n=98, Control n=92)	32.50 kg/m² Standard Deviation 4.177	33.96 kg/m² Standard Deviation 3.517

POST_HOC outcome

Timeframe: Baseline, Week 26, Week 39, Week 52

Population: Randomized participants in the ITT population with last observed carried forward (number of participants varies as not all participants provided data at each timepoint)

Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' mean %EWL (using a BMI=25 kg/m² as ideal weight) at key timepoints. Participants' mean %EWL was assessed at Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion). Percent EWL was calculated as %EWL= (weight loss divided by excess weight)\*100, where Weight loss = Baseline weight - selected follow-up weight, and Excess weight = Baseline weight - ideal weight, where ideal weight was BMI=25.

Outcome measures

Outcome measures
Measure	BIB® n=125 Participants Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=130 Participants Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Percent EWL (Using BMI=25 kg/m²) Week 26 (BIB n=117, Control n=91)	38.4 percentage of EWL Standard Deviation 27.61	12.1 percentage of EWL Standard Deviation 18.58
Percent EWL (Using BMI=25 kg/m²) Week 39 (BIB n=91, Control n=95)	34.6 percentage of EWL Standard Deviation 28.4	12.3 percentage of EWL Standard Deviation 19.33
Percent EWL (Using BMI=25 kg/m²) Week 52 (BIB n=98, Control n=92)	29.0 percentage of EWL Standard Deviation 30.70	11.1 percentage of EWL Standard Deviation 20.67

POST_HOC outcome

Timeframe: Baseline, Week 26, Week 39, Week 52

Population: Randomized participants in the ITT population with last observation carried forward. n=number of participants (number of participants varies as not all participants provided data at each timepoint).

Post-Hoc effectiveness analyses were performed per the request of FDA after the study closed, therefore the protocol was not amended. The data was analyzed to determine participants' Percent Total Body Weight Loss (%TBWL) at key timepoints throughout the study. The mean %TBWL for the BIB and Control group was assessed at baseline, Week 26 (6 months, balloon removal for BIB group), Week 39 (9 months), and Week 52 (12, months, study completion).

Outcome measures

Outcome measures
Measure	BIB® n=125 Participants Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=130 Participants Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Percent Total Body Weight Loss (%TBWL) Week 26 (BIB n=117, Control n=91)	10.2 percentage of TBWL Interval 9.0 to 11.4	3.3 percentage of TBWL Interval 2.4 to 4.2
Percent Total Body Weight Loss (%TBWL) Week 39 (BIB n=91, Control n=93)5	9.1 percentage of TBWL Interval 7.9 to 10.3	3.4 percentage of TBWL Interval 2.4 to 4.3
Percent Total Body Weight Loss (%TBWL) Week 52 (BIB n=98, Control n=92)	7.6 percentage of TBWL Interval 6.2 to 8.9	3.1 percentage of TBWL Interval 2.0 to 4.1

Adverse Events

BIB®

Serious events: 19 serious events

Other events: 124 other events

Deaths: 0 deaths

Control

Serious events: 8 serious events

Other events: 92 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Laura Eaton, Study Director, RN, BSN, CCRN-R,

Apollo Endosurgery

Phone: 949-468-9301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	BIB® n=125 participants at risk Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=130 participants at risk Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Blood and lymphatic system disorders Chronic myelogenous leukemia	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Cardiac disorders Syncope	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Endocrine disorders Hyperparathyroidism	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Irritable bowel syndrome	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Ventral hernia	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Diverticulitis	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Investigations Device Intolerance	6.4% 8/125 • Number of events 8 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Gastric outlet obstruction	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Metabolism and nutrition disorders Dehydration	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
General disorders Defective device	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Hepatobiliary disorders Choledocholithiasis	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Hepatobiliary disorders Cholelithiasis	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.77% 1/130 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Infections and infestations Giardia lamblia infection	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Infections and infestations Viral gastroparesis	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Musculoskeletal and connective tissue disorders Osteoarthritis of the hip	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Reproductive system and breast disorders Dysmenorrhea	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Reproductive system and breast disorders Breast abscess	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Reproductive system and breast disorders Ovarian cyst	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.77% 1/130 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.80% 1/125 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Endocrine disorders Hemithyroidectomy	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.77% 1/130 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Hepatobiliary disorders Sphincter of Oddi dysfunction	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.77% 1/130 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Injury, poisoning and procedural complications Motor vehicle accident with nasal fracture	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.77% 1/130 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Musculoskeletal and connective tissue disorders Herniated lumbar disc	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.77% 1/130 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Renal and urinary disorders Renal cell carcinoma with nephrectomy	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.77% 1/130 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Vascular disorders Bilateral vertebral artery hypoplasia	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.77% 1/130 • Number of events 1 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.

Other adverse events
Measure	BIB® n=125 participants at risk Receives BioEnterics® Intragastric Balloon Intervention as well as diet and exercise counseling with the Behavioral Modification Intervention. BioEnterics® Intragastric Balloon: Inflatable balloon inserted into the stomach. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise	Control n=130 participants at risk Control arm receives the Behavioral modification intervention only. Behavioral modification: Low-calorie diet, food/exercise diary, eating plan, emphasis on exercise
Gastrointestinal disorders Abdominal Distension	18.4% 23/125 • Number of events 23 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	3.1% 4/130 • Number of events 4 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Abdominal Pain	64.8% 81/125 • Number of events 81 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	3.8% 5/130 • Number of events 5 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Abdominal Pain Upper	18.4% 23/125 • Number of events 23 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Constipation	24.8% 31/125 • Number of events 31 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	4.6% 6/130 • Number of events 6 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Diarrhea	20.0% 25/125 • Number of events 25 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	6.9% 9/130 • Number of events 9 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Dyspepsia	24.0% 30/125 • Number of events 30 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Eructation	23.2% 29/125 • Number of events 29 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Flatulence	11.2% 14/125 • Number of events 14 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Gastroesophageal Reflux Disease (GERD)	30.4% 38/125 • Number of events 38 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	4.6% 6/130 • Number of events 6 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Impaired Gastric Emptying	12.8% 16/125 • Number of events 16 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	3.8% 5/130 • Number of events 5 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Nausea	89.6% 112/125 • Number of events 112 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	5.4% 7/130 • Number of events 7 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Gastrointestinal disorders Vomiting	77.6% 97/125 • Number of events 97 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	5.4% 7/130 • Number of events 7 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
General disorders Asthenia	8.0% 10/125 • Number of events 10 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
General disorders Fatigue	7.2% 9/125 • Number of events 9 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Infections and infestations Bronchitis	7.2% 9/125 • Number of events 9 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	8.5% 11/130 • Number of events 11 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Infections and infestations Ear Infection	4.0% 5/125 • Number of events 5 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	3.1% 4/130 • Number of events 4 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Infections and infestations Nasopharyngitis	4.8% 6/125 • Number of events 6 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	5.4% 7/130 • Number of events 7 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Infections and infestations Pharyngitis streptococcal	3.2% 4/125 • Number of events 4 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	4.6% 6/130 • Number of events 6 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Infections and infestations Sinusitis	8.8% 11/125 • Number of events 11 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	14.6% 19/130 • Number of events 19 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Infections and infestations Upper respiratory tract infection	8.0% 10/125 • Number of events 10 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	10.0% 13/130 • Number of events 13 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Infections and infestations Viral infection	4.8% 6/125 • Number of events 6 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Injury, poisoning and procedural complications Medical device complication	6.4% 8/125 • Number of events 8 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Injury, poisoning and procedural complications Post procedural pain	7.2% 9/125 • Number of events 9 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Investigations Blood cholesterol increased	4.8% 6/125 • Number of events 6 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Metabolism and nutrition disorders Dehydration	13.6% 17/125 • Number of events 17 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 6/125 • Number of events 6 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	6.9% 9/130 • Number of events 9 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	3.1% 4/130 • Number of events 4 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Nervous system disorders Headache	8.8% 11/125 • Number of events 11 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	5.4% 7/130 • Number of events 7 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Psychiatric disorders Anxiety	4.0% 5/125 • Number of events 5 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Respiratory, thoracic and mediastinal disorders Cough	4.8% 6/125 • Number of events 6 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 5/125 • Number of events 5 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Skin and subcutaneous tissue disorders Rash	5.6% 7/125 • Number of events 7 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	0.00% 0/130 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Vascular disorders Hypertension	3.2% 4/125 • Number of events 4 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	4.6% 6/130 • Number of events 6 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Investigations Blood thyroid stimulating hormone decreased	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	3.1% 4/130 • Number of events 4 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Investigations Vitamin B1 decreased	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	3.8% 5/130 • Number of events 5 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	7.7% 10/130 • Number of events 10 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.
Nervous system disorders Migraine	0.00% 0/125 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.	3.1% 4/130 • Number of events 4 • Adverse event (AE) data was collected over a period of 12 months. AE data was collected beginning with the start of treatment (BIB placement and behavioral modification program for BIB group; behavioral modification program alone for the Control group) and at follow-up visits throughout the study, for a total of 12 months. Both device-related and non-device-related AEs are reported below.