Trial Outcomes & Findings for Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2 (NCT NCT00570505)

Last Updated: 2015-03-17

Results Overview

The percent of subjects attaining clinically successful weight loss at 1 year post LAP-BAND implantation. Clinically successful weight loss was defined as ≥ 30% Excess Weight Loss (%EWL), where %EWL was weight loss divided by excess weight multiplied by 100.

Recruitment status

COMPLETED

Study phase

Target enrollment

151 participants

Primary outcome timeframe

One year

Results posted on

2015-03-17

Participant Flow

155 Subjects were enrolled per protocol (defined as signing the informed consent). After enrollment, 4 subjects withdrew consent prior to treatment, and 2 subjects were not implanted due to ineligibility discovered during screening. This resulted in 149 subjects starting the study and receiving treatment with the LAP-BAND System.

Participant milestones

Participant milestones
Measure	LapBand All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch
Overall Study STARTED	149
Overall Study COMPLETED	108
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Reasons for withdrawal
Measure	LapBand All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch
Overall Study Adverse Event	7
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	23
Overall Study Other loss to follow-up	4

Baseline Characteristics

Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LapBand n=149 Participants Subjects implanted with the LapBand(R) Adjustable Gastric Band System
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	147 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.28 years STANDARD_DEVIATION 9.304 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	149 participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Intent-to-treat (ITT)

Outcome measures

Outcome measures
Measure	LapBand n=143 Participants All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch
Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation	83.9 percentage of subjects

SECONDARY outcome

Timeframe: Baseline through 12 months

Population: Intent-to-treat (ITT)

Percent weight loss was defined as weight loss divided by baseline weight, multiplied by 100. Weight loss was equal to baseline weight minus the follow-up visit weight. Excess weight = baseline weight minus ideal weight, where ideal weight was determined based on a BMI of 25 kg/m2.

Outcome measures

Outcome measures
Measure	LapBand n=143 Participants All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch
Percent Weight Loss	18.32 percentage of weight loss Standard Deviation 8.516

SECONDARY outcome

Timeframe: 12 months

Population: Subjects who had the specific comorbid condition at baseline (Diabetes n = 6, Dyslipidemia n = 29, Hypertension n = 27)

Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved (i.e., was rated as "none" on a severity scale of none, mild, moderate, or severe) 12 months after implantation.

Outcome measures

Outcome measures
Measure	LapBand n=143 Participants All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch
Change in Comorbid Conditions Related to Obesity Hypertension (n = 27)	22.2 percentage of subjects
Change in Comorbid Conditions Related to Obesity Diabetes Type II (n = 6)	33.3 percentage of subjects
Change in Comorbid Conditions Related to Obesity Dyslipidemia (n = 29)	27.6 percentage of subjects

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-treat (ITT)

Change in quality of life was assessed using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) Total Score, which ranges from 0 (worst) to 100 (best). The mean change from baseline to 12 months in IWQOL-Lite Total Score is reported.

Outcome measures

Outcome measures
Measure	LapBand n=143 Participants All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch
Change in Quality of Life	28.03 units on a scale Standard Deviation 17.274

POST_HOC outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT)

The percent of subjects who attained clinically successful weight loss (ie, ≥ 30% Excess Weight Loss) at year 5 post LAP-BAND implantation. Percent EWL =(weight loss divided by excess weight)\*100. Excess Weight was defined as Baseline Weight - Ideal Weight, where Ideal Weight was a BMI of 25 kg/m2.

Outcome measures

Outcome measures
Measure	LapBand n=108 Participants All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch
Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 5 Years Post LAP-BAND Implantation	76.9 percentage of subjects Interval 67.75 to 84.43

POST_HOC outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT)

The mean percent excess weight loss (%EWL) for subjects at month 60. Percent EWL = (weight loss divided by excess weight)\*100.

Outcome measures

Outcome measures
Measure	LapBand n=108 Participants All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch
Subject Percent Excess Weight Loss (5 Years)	62.74 percentage of excess weight loss Standard Deviation 41.131

POST_HOC outcome

Timeframe: 5 years

Population: Subjects who had the specific comorbid condition at screening (Type 2 Diabetes n=5, Dyslipidemia n=45, Hypertension n=49)

Percent of subjects whose baseline comorbid condition of Type 2 diabetes, dyslipidemia, and hypertension resolved 5 years post LAP-BAND implantation. Diabetes resolution was defined as HbA1c ≤ 6% and no diabetes medication usage. Dyslipidemia resolution was defined as HDL ≥ 60 mg/dL, LDL \< 100 mg/dL, triglycerides \< 150 mg/dL, and total cholesterol \< 200 mg/dL. Hypertension resolution was defined as systolic blood pressure \< 140 mm Hg.

Outcome measures

Outcome measures
Measure	LapBand n=108 Participants All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch
Change in Obesity Related Comorbid Conditions (5 Years) Type 2 Diabetes (n=5)	40.0 percentage of subjects
Change in Obesity Related Comorbid Conditions (5 Years) Dyslipidemia (n=45)	4.4 percentage of subjects
Change in Obesity Related Comorbid Conditions (5 Years) Hypertension (n=49)	12.2 percentage of subjects

POST_HOC outcome

Timeframe: 5 years

Population: Intent-to-treat (ITT)

Outcome measures

Outcome measures
Measure	LapBand n=104 Participants All subjects who receive the LAP-BAND System. LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch
Change in Quality of Life (5 Years)	29.23 units on a scale Standard Deviation 19.397

Adverse Events

LapBand

Serious events: 18 serious events

Other events: 145 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LapBand n=149 participants at risk Subjects implanted with the LapBand(R) Adjustable Gastric Band System
Gastrointestinal disorders Abdominal cavity abscess	0.67% 1/149 • Number of events 1 • 5 years
Gastrointestinal disorders Band erosion	1.3% 2/149 • Number of events 2 • 5 years
Gastrointestinal disorders Abdominal Pain	0.67% 1/149 • Number of events 1 • 5 years
Respiratory, thoracic and mediastinal disorders Dysphagia	0.67% 1/149 • Number of events 1 • 5 years
Gastrointestinal disorders Gastric outlet obstruction	3.4% 5/149 • Number of events 5 • 5 years
Respiratory, thoracic and mediastinal disorders Esophageal spasms	0.67% 1/149 • Number of events 1 • 5 years
Gastrointestinal disorders Gastric prolapse	2.7% 4/149 • Number of events 4 • 5 years
General disorders Umbilical hernia contained LAP-BAND tubing	0.67% 1/149 • Number of events 1 • 5 years
Gastrointestinal disorders Recurrent gastric stricture	0.67% 1/149 • Number of events 1 • 5 years
Gastrointestinal disorders Vomiting	0.67% 1/149 • Number of events 1 • 5 years
Gastrointestinal disorders Band slip	2.7% 4/149 • Number of events 6 • 5 years
Gastrointestinal disorders Hiatal hernia	0.67% 1/149 • Number of events 1 • 5 years
Renal and urinary disorders Biliary colic	0.67% 1/149 • Number of events 1 • 5 years
Renal and urinary disorders Cholelithiasis	0.67% 1/149 • Number of events 1 • 5 years
Gastrointestinal disorders Pouch dilation	0.67% 1/149 • Number of events 1 • 5 years
Respiratory, thoracic and mediastinal disorders Esophageal obstruction	0.67% 1/149 • Number of events 1 • 5 years

Other adverse events

Other adverse events
Measure	LapBand n=149 participants at risk Subjects implanted with the LapBand(R) Adjustable Gastric Band System
Gastrointestinal disorders Vomiting	69.8% 104/149 • Number of events 104 • 5 years
Gastrointestinal disorders Dysphagia	49.0% 73/149 • Number of events 73 • 5 years
Gastrointestinal disorders Gastroesophageal reflux disease	51.7% 77/149 • Number of events 77 • 5 years
Gastrointestinal disorders Dyspepsia	20.1% 30/149 • Number of events 30 • 5 years
Gastrointestinal disorders Nausea	16.1% 24/149 • Number of events 24 • 5 years
Gastrointestinal disorders Gastric dilation	12.8% 19/149 • Number of events 19 • 5 years
Gastrointestinal disorders Abdominal pain	10.7% 16/149 • Number of events 16 • 5 years
Gastrointestinal disorders Regurgitation of food	10.7% 16/149 • Number of events 16 • 5 years
Gastrointestinal disorders Esophageal dilation	8.1% 12/149 • Number of events 12 • 5 years
Gastrointestinal disorders Abdominal pain upper	7.4% 11/149 • Number of events 11 • 5 years
Gastrointestinal disorders Constipation	5.4% 8/149 • Number of events 8 • 5 years
Gastrointestinal disorders Diarrhea	5.4% 8/149 • Number of events 8 • 5 years
Injury, poisoning and procedural complications Post procedural pain	19.5% 29/149 • Number of events 29 • 5 years
Injury, poisoning and procedural complications Medical device complication	16.8% 25/149 • Number of events 25 • 5 years
General disorders Implant site pain	8.1% 12/149 • Number of events 12 • 5 years
Respiratory, thoracic and mediastinal disorders Cough	6.0% 9/149 • Number of events 9 • 5 years
Blood and lymphatic system disorders Anemia	5.4% 8/149 • Number of events 8 • 5 years
Metabolism and nutrition disorders Dehydration	5.4% 8/149 • Number of events 8 • 5 years

Additional Information

Laura Eaton

Apollo Endosurgery

Phone: 949-468-9301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER