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

March 12, 2015 updated by: Apollo Endosurgery, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LapBand
All subjects who receive the LAP-BAND System.
Device: LAP-BAND System
Reduction of food intake due to creation of smaller stomach pouch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation
Time Frame: 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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Weight Loss
Time Frame: 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.
Baseline through 12 months
Change in Comorbid Conditions Related to Obesity
Time Frame: 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.
12 months
Change in Quality of Life
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apollo Endosurgery, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • LBMI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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