LAP-BAND Observational Cohort

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00283972
Study type	Observational
Source	Inamed
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	June 2005
Completion date	December 2006

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