LAP-BAND Observational Cohort

Inflammation Clinical Trial

Official title:

Health Outcome Study of LAP-BAND Adjustable Gastric Banding System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00283972
• Other study ID #: 12242004P
• 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
• 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

Related Conditions & MeSH terms

• Epworth Sleepiness Scale
• Glycemic Control
• Inflammation
• Iron and Bone Turnover
• IW-QOL Lite HRQoL
• Liver Function
• SF-36

Intervention

Device:
• LAP-BAND System

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Inamed	VA Office of Research and Development