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
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: LAP-BAND System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||November 2013|
All subjects who receive the LAP-BAND System.
Device: LAP-BAND System
Reduction of food intake due to creation of smaller stomach pouch
- 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.
- 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.
- 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.
- 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.
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
|United States, Washington|
|Seattle, Washington, United States|