This trial is active, not recruiting.

Conditions epworth sleepiness scale, glycemic control, liver function, inflammation, iron and bone turnover, sf-36, iw-qol lite hrqol
Treatment lap-band system
Phase phase 4
Sponsor Inamed
Collaborator Department of Veterans Affairs
Start date June 2005
End date December 2006
Trial size 240 participants
Trial identifier NCT00283972, 12242004P


To prospectively observe the association of the LAP-BAND procedure on quality of life, anthropometric, metabolic and biochemical parameters in morbidly obese patients when performed by experienced US surgeons. The study will also include a complete economic analysis of the LAP-BAND procedure and follow-up costs Hypothesis: Measurements defining quality of life and the severity of obesity and obesity related comorbidities improve significantly over baseline with the LAP-BAND System treatment at 6 and 12 months post surgery when performed by an experienced surgeon.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model defined population
Time perspective longitudinal

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Morbid Obesity: BMI >40 kg/m2 or - BMI > or equal to 35 kg/m2 with significant obesity related comorbidity - Age 18 years old or older - Dietary attempts at weight control have been ineffective - Consented for surgery with LAP-BAND System by pre qualified bariatric surgeon - Willingness and ability to follow protocol requirements - Residing within a reasonable distance from the surgeon's office and being able to travel to the surgeon's office to complete all routine follow-up visits Exclusion Criteria: - Previous bariatric surgery - Psychological impairments that would impede compliance with study follow up schedule, as determined by attending surgeons

Additional Information

Official title Health Outcome Study of LAP-BAND Adjustable Gastric Banding System
Principal investigator Louis Fiore, MD
Description Study Type: Observational cohort. Single arm (non-comparative), non-randomized, multi-site surgical case series. Objective: To prospectively observe the association of the LAP-BAND System device on measurements of quality of life, anthropometric, metabolic and biochemical parameters in morbidly obese patients when performed by experienced U.S. surgeons. Cost effectiveness analysis will also be done. Numbers: This study will enroll 240 patients total from six U.S. bariatric surgical practices Duration: Individual subject participation will be approximately 15 months. Data will be collected at a baseline less than three months prior to surgery or before starting a Very Low Calorie Diet (VLCD), then at 6 and 12 months post surgery. The total duration, including enrollment, of the observational period for the cohort is expected to be 21 months. Subjects have the option to consent for future contact by investigators for a period of 10 years following their surgery.
Trial information was received from ClinicalTrials.gov and was last updated in January 2006.
Information provided to ClinicalTrials.gov by Inamed.