Inflammation Clinical Trial
Official title:
Health Outcome Study of LAP-BAND Adjustable Gastric Banding System
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.
Status | Active, not recruiting |
Enrollment | 240 |
Est. completion date | December 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Defined Population, Time Perspective: Longitudinal
Country | Name | City | State |
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Lead Sponsor | Collaborator |
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Inamed | VA Office of Research and Development |
Status | Clinical Trial | Phase | |
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