Status:
UNKNOWN
LAP-BAND Observational Cohort
Lead Sponsor:
Inamed
Collaborating Sponsors:
Massachusetts Veterans Epidemiology Research and Information Center
Conditions:
Epworth Sleepiness Scale
Glycemic Control
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed 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 m...
Eligibility Criteria
Inclusion
- 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
- Previous bariatric surgery
- Psychological impairments that would impede compliance with study follow up schedule, as determined by attending surgeons
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
End Date :
December 1 2006
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00283972
Start Date
June 1 2005
End Date
December 1 2006
Last Update
January 31 2006
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.