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

Apollo Endosurgery, Inc.151 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

151

Conditions

Obesity

Interventions

LAP-BAND SystemDEVICE

Reduction of food intake due to creation of smaller stomach pouch

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

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