Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI >/= 30 kg/m2 and < 40 kg/m2
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: December 10, 2007
Last updated: December 17, 2012
Last verified: December 2012
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 Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Resource links provided by NLM:
Further study details as provided by Allergan Medical:
Primary Outcome Measures:
- Percent of Subjects Who Attain Clinically Successful Weight Loss of ≥30% Excess Weight Loss (EWL) at 1 Year Post LAP-BAND Implantation. Percent EWL Was Defined as Weight Loss Divided by Excess Weight Multiplied by 100. [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- % 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 from baseline score on the IWQOL-Lite Total Score, where 0 is worst and 100 is best.
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||November 2013|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Device: LAP-BAND System
Reduction of food intake due to creation of smaller stomach pouch
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