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

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ClinicalTrials.gov Identifier: NCT00570505
Recruitment Status : Completed
First Posted : December 11, 2007
Results First Posted : December 3, 2012
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Apollo Endosurgery, Inc.

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.

Condition or disease Intervention/treatment Phase
Obesity Device: LAP-BAND System Not Applicable

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  (Clinical Trial)
Actual Enrollment : 151 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2013

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570505


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

Publications of Results:
Responsible Party: Apollo Endosurgery, Inc.
ClinicalTrials.gov Identifier: NCT00570505     History of Changes
Other Study ID Numbers: LBMI-001
First Posted: December 11, 2007    Key Record Dates
Results First Posted: December 3, 2012
Last Update Posted: March 17, 2015
Last Verified: March 2015