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

This study has been completed.
Information provided by (Responsible Party):
Apollo Endosurgery, Inc. Identifier:
First received: December 10, 2007
Last updated: March 12, 2015
Last verified: March 2015
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.

Condition Intervention
Device: LAP-BAND System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Apollo Endosurgery, Inc.:

Primary Outcome Measures:
  • Percent of Subjects Attaining Clinically Successful Weight Loss ( ≥ 30% EWL) at 1 Year Post LAP-BAND Implantation [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percent Weight Loss [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

Enrollment: 151
Study Start Date: November 2007
Study Completion Date: November 2013
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00570505

United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Apollo Endosurgery, Inc.
  More Information

Responsible Party: Apollo Endosurgery, Inc. Identifier: NCT00570505     History of Changes
Other Study ID Numbers: LBMI-001 
Study First Received: December 10, 2007
Results First Received: July 23, 2012
Last Updated: March 12, 2015
Health Authority: United States: Food and Drug Administration processed this record on October 25, 2016