LapBand Adjustment to Improve Early Weight Loss

Phase 2

Completed

• Conditions: Obesity

• Registration Number: NCT01060592
• Lead Sponsor: Crospon

Brief Summary

Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-01-30
• Study First Submitted QC: 2010-01-30
• Study First Posted: 2010-02-02
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Results First Submitted: 2013-02-20
• Results First Submitted QC: 2013-03-26
• Status Verified: 2013-04
• Results First Posted: 2013-04-04
• Last Update Submitted: 2013-04-04
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients undergoing gastric band surgery
• Over 18 years of age

Exclusion Criteria

• Actively bleeding varices

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)	4-6 weeks post surgery
%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)	4-6 weeks post surgery
% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)	12m post surgery
% Excess Weight Loss 12 Months After Surgery (Small Bands Only)	12m post surgery

Secondary Outcome Measures

Name	Time	Method
Number of Band Adjustments Required in the First Year After Surgery	12 months

Trial Locations

Locations (1)

Specialty Surgery of Fort Worth; 🇺🇸 Hurst, Texas, United States