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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00283972
Other study ID # 12242004P
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received January 24, 2006
Last updated January 30, 2006
Start date June 2005
Est. completion date December 2006

Study information

Verified date January 2006
Source Inamed
Contact n/a
Is FDA regulated No
Health authority United States: Office for Human Resource Protections (OHRP)United States: Registration # IRB00000755
Study type Observational

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.


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.


Recruitment information / eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Intervention

Device:
LAP-BAND System


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Inamed VA Office of Research and Development
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