Obesity
Conditions
Brief summary
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and \< 40 kg/m2.
Detailed description
LBMI-001 is a multi-center, prospective, longitudinal, non-randomized study whose purpose is to determine whether the LAP-BAND system is safe and effective in subjects with BMI ≥ 30 kg/m2 and \< 40 kg/m2. Primary and secondary outcome measures were analyzed at 1 year post LAP-BAND implantation. Subjects continued to be followed for 5 years post-implantation, and 5 year data was evaluated in Post-Hoc outcome measures.
Interventions
DEVICELAP-BAND System
Reduction of food intake due to creation of smaller stomach pouch
Sponsors
Apollo Endosurgery, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Have a BMI ≥ 30 kg/m2 and \< 35 kg/m2 (with or without comorbid conditions) or a BMI ≥ 35 kg/m2 and \< 40 kg/m2 without severe comorbid conditions * Have a history of obesity for at least 2 years and have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs
Exclusion criteria
* Subject history of congenital or acquired anomalies of the gastrointestinal tract * Severe cardiopulmonary or other serious or uncontrolled organic disease * Severe coagulopathy; hepatic insufficiency or cirrhosis * History of bariatric; gastric; or esophageal surgery * History of intestinal obstruction or adhesive peritonitis * History of esophageal dysmotility disorders * Type I diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation | One year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Loss | Baseline through 12 months | 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. |
| Change in Comorbid Conditions Related to Obesity | 12 months | 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. |
| Change in Quality of Life | 12 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| LapBand Subjects implanted with the LapBand(R) Adjustable Gastric Band System | 149 |
| Total | 149 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Lost to Follow-up | 23 |
| Overall Study | Other loss to follow-up | 4 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | LapBand |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 147 Participants |
| Age, Continuous | 39.28 years STANDARD_DEVIATION 9.304 |
| Region of Enrollment United States | 149 participants |
| Sex: Female, Male Female | 135 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 145 / 149 |
| serious Total, serious adverse events | 18 / 149 |
Outcome results
Primary
Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation
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.
Time frame: One year
Population: Intent-to-treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LapBand | Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation | 83.9 percentage of subjects |
Secondary
Change in Comorbid Conditions Related to Obesity
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.
Time frame: 12 months
Population: Subjects who had the specific comorbid condition at baseline (Diabetes n = 6, Dyslipidemia n = 29, Hypertension n = 27)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LapBand | Change in Comorbid Conditions Related to Obesity | Dyslipidemia (n = 29) | 27.6 percentage of subjects |
| LapBand | Change in Comorbid Conditions Related to Obesity | Hypertension (n = 27) | 22.2 percentage of subjects |
| LapBand | Change in Comorbid Conditions Related to Obesity | Diabetes Type II (n = 6) | 33.3 percentage of subjects |
Secondary
Change in Quality of Life
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.
Time frame: 12 months
Population: Intent-to-treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LapBand | Change in Quality of Life | 28.03 units on a scale | Standard Deviation 17.274 |
Secondary
Percent Weight Loss
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.
Time frame: Baseline through 12 months
Population: Intent-to-treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LapBand | Percent Weight Loss | 18.32 percentage of weight loss | Standard Deviation 8.516 |
Post Hoc
Change in Obesity Related Comorbid Conditions (5 Years)
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.
Time frame: 5 years
Population: Subjects who had the specific comorbid condition at screening (Type 2 Diabetes n=5, Dyslipidemia n=45, Hypertension n=49)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LapBand | Change in Obesity Related Comorbid Conditions (5 Years) | Type 2 Diabetes (n=5) | 40.0 percentage of subjects |
| LapBand | Change in Obesity Related Comorbid Conditions (5 Years) | Dyslipidemia (n=45) | 4.4 percentage of subjects |
| LapBand | Change in Obesity Related Comorbid Conditions (5 Years) | Hypertension (n=49) | 12.2 percentage of subjects |
Post Hoc
Change in Quality of Life (5 Years)
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 5 years in IWQOL-Lite Total Score is reported.
Time frame: 5 years
Population: Intent-to-treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LapBand | Change in Quality of Life (5 Years) | 29.23 units on a scale | Standard Deviation 19.397 |
Post Hoc
Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 5 Years Post LAP-BAND Implantation
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.
Time frame: 5 years
Population: Intent-to-treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LapBand | Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 5 Years Post LAP-BAND Implantation | 76.9 percentage of subjects |
Post Hoc
Subject Percent Excess Weight Loss (5 Years)
The mean percent excess weight loss (%EWL) for subjects at month 60. Percent EWL = (weight loss divided by excess weight)\*100.
Time frame: 5 years
Population: Intent-to-treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LapBand | Subject Percent Excess Weight Loss (5 Years) | 62.74 percentage of excess weight loss | Standard Deviation 41.131 |