Trial Outcomes & Findings for Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents (NCT NCT00447590)

NCT ID: NCT00447590

Last Updated: 2014-10-02

Results Overview

Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100. Excess Weight = baseline weight - ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 153 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2014-10-02

Participant Flow

174 participants were enrolled in the study, where enrollment was defined as signing the informed consent form. 21 participants were not implanted after signing the informed consent. 153 participants were treated with the LAP-BAND.

Participant milestones

Measure	LAP-BAND All subjects who received the LAP-BAND System.
Overall Study STARTED	153
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	60

Reasons for withdrawal

Measure	LAP-BAND All subjects who received the LAP-BAND System.
Overall Study Withdrawal by Subject	26
Overall Study Lost to Follow-up	24
Overall Study Band Removed/Eroded/Other Follow-Up Loss	10

Baseline Characteristics

Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents

Baseline characteristics by cohort

Measure	LAP-BAND n=153 Participants All subjects who received the LAP-BAND System.
Age, Continuous	15.8 years n=5 Participants
Age, Customized Age 14	25 participants n=5 Participants
Age, Customized Age 15	33 participants n=5 Participants
Age, Customized Age 16	47 participants n=5 Participants
Age, Customized Age 17	46 participants n=5 Participants
Age, Customized Age 18	2 participants n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	102 participants n=5 Participants
Race/Ethnicity, Customized Black/African-American	37 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	10 participants n=5 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants
Body Mass Index (BMI)	48.5 kg/m2 n=5 Participants
Excess Weight	152.3 pounds (lb) n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Intent to treat (ITT) population with imputation at month 12 (ITT population consisted of participants treated with the LAP-BAND).

Percent Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.

Excess Weight = baseline weight - ideal weight, where Ideal weight was determined using the 85th percentile on the Centers for Disease Control (CDC) Growth Charts for children and adolescents ages 2 to 20 years.

Outcome measures

Measure	LAP-BAND n=153 Participants All subjects who received the LAP-BAND System.
Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation.	49.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline to 5 Years

Population: Intent to treat (ITT) population with imputation at month 60

Excess Weight Loss was examined over the 5 year period post LAP-BAND implantation. Excess Weight Loss was defined as Weight Loss divided by Excess Weight multiplied by 100.

Outcome measures

Measure	LAP-BAND n=153 Participants All subjects who received the LAP-BAND System.
Subject Excess Weight Loss Throughout the Study	27.0 %EWL Standard Deviation 45.46 • Interval 19.69 to 34.21

SECONDARY outcome

Timeframe: Baseline to 5 Years

Population: Intent to treat (ITT) population with imputation at month 60

Subject Percent Excess BMI Loss was examined at 5 years post LAP-BAND placement.

Outcome measures

Measure	LAP-BAND n=153 Participants All subjects who received the LAP-BAND System.
Subject Percent Excess BMI Loss	-6.0 kg/m2 95% Confidence Interval 11.12 • Interval -7.41 to -4.62

SECONDARY outcome

Timeframe: Baseline to 5 Years

Population: Subjects who had a specific comorbid condition at baseline (Diabetes n=9, Dyslipidemia n=39, Hypertension n=22)

The change from baseline to year five in subjects' comorbid conditions of Type II Diabetes, Dyslipidemia, and Hypertension. Change as reported below indicates the condition resolved.

Outcome measures

Measure	LAP-BAND n=70 Participants All subjects who received the LAP-BAND System.
Change in Subjects' Comorbid Conditions Diabetes Type II (n=9)	3 participants whose condition resolved
Change in Subjects' Comorbid Conditions Dyslipidemia (n=39)	14 participants whose condition resolved
Change in Subjects' Comorbid Conditions Hypertension (n=22)	7 participants whose condition resolved

SECONDARY outcome

Timeframe: Baseline to 5 Years

Population: Participants who completed the BDI II questionnaire through month 60

Quality of life was examined using the Beck Depression Inventory II (BDI) questionnaire, which scores on a range from 0 (best) to 63 (worst). The change in subjects' BDI II score was assessed from baseline to 5 years.

Outcome measures

Measure	LAP-BAND n=74 Participants All subjects who received the LAP-BAND System.
Change in Quality of Life Using the Beck Depression Inventory II (BDI)	-1.0 units on BDI scale Interval -2.64 to 0.39

SECONDARY outcome

Timeframe: Baseline to 5 Years

Population: Participants who completed the IWQOL Kids questionnaire through month 60 (year 5).

Quality of life was examined using the Impact of Weight on Quality of Life (IWQOL) Kids questionnaire, which has a score range from 0(worst) to 100(best). The change in subjects' IWQOL Kids score was assessed from baseline to 5 years.

Outcome measures

Measure	LAP-BAND n=72 Participants All subjects who received the LAP-BAND System.
Change in Quality of Life Using Impact of Weight on Quality of Life (IWQOL) Kids Questionnaire	18.0 units on IWQOL Kids scale Interval 14.42 to 21.59

Adverse Events

LAP-BAND

Serious events: 20 serious events

Other events: 133 other events

Deaths: 0 deaths

Serious adverse events

Measure	LAP-BAND n=153 participants at risk All subjects who received the LAP-BAND System.
Gastrointestinal disorders Abdominal Pain	1.3% 2/153 • Number of events 2 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Band Slip	5.9% 9/153 • Number of events 9 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Band erosion	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Metabolism and nutrition disorders Dehydration	2.6% 4/153 • Number of events 4 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Duodenitis	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Esophageal irritation	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Esophagus distended	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Gastric erosion	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Gastric herniation via Lap-Band	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Gastric prolapse	1.3% 2/153 • Number of events 2 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Gastritis	1.3% 2/153 • Number of events 2 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Hematemesis	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Hiatal hernia	1.3% 2/153 • Number of events 2 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Intra-abdominal sepsis	0.65% 1/153 • Number of events 2 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Large gastric pouch	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Surgical and medical procedures Port Tubing disconnect	1.3% 2/153 • Number of events 2 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Possible acute obstruction of the Lap-Band	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Recurrent pouch enlargement	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Stomach Pain	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Infections and infestations Surgical site infection	0.65% 1/153 • Number of events 1 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Vomiting	2.0% 3/153 • Number of events 3 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.

Other adverse events

Measure	LAP-BAND n=153 participants at risk All subjects who received the LAP-BAND System.
Gastrointestinal disorders Vomiting	54.2% 83/153 • Number of events 83 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Gastric dilatation	40.5% 62/153 • Number of events 62 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Dysphagia	24.8% 38/153 • Number of events 38 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Gastrooesophageal reflux disease	20.3% 31/153 • Number of events 31 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Abdominal pain	19.6% 30/153 • Number of events 30 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Nausea	19.6% 30/153 • Number of events 30 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Dyspepsia	18.3% 28/153 • Number of events 28 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Oesophageal dilatation	17.0% 26/153 • Number of events 26 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Abdominal pain upper	8.5% 13/153 • Number of events 13 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Diarrhoea	7.8% 12/153 • Number of events 12 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Gastrointestinal disorders Hiatus hernia	5.2% 8/153 • Number of events 8 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Injury, poisoning and procedural complications Medical device complication	15.7% 24/153 • Number of events 24 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Injury, poisoning and procedural complications Post procedural pain	9.2% 14/153 • Number of events 14 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Injury, poisoning and procedural complications Device failure	7.8% 12/153 • Number of events 12 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
General disorders Implant site pain	5.2% 8/153 • Number of events 8 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
General disorders Non-cardiac chest pain	4.6% 7/153 • Number of events 7 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Metabolism and nutrition disorders Dehydration	4.6% 7/153 • Number of events 7 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Musculoskeletal and connective tissue disorders Shoulder pain	3.9% 6/153 • Number of events 6 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.
Nervous system disorders Dizziness	3.9% 6/153 • Number of events 6 • Adverse Event information was collected from the time of LAP-BAND implantation to 5 years (end of study). Device-related Serious Adverse Events (SAEs) and Adverse Events (AEs) are reported. AEs occurring with frequency of \>=1% are reported.

Additional Information

Laura Eaton, R.N., BSN, CCRN-R

Apollo Endosurgery

Phone: 949-468-9301

Email: laura.eaton@apolloendo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place