Back to resultsLapBand Adjustment to Improve Early Weight Loss
Primary Purpose
Obesity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EndoFLIP device (FDA Device Listing Number : D091203)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Gastric Band, LapBand, Bariatric Surgery
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing gastric band surgery
- Over 18 years of age
Exclusion Criteria:
- Actively bleeding varices
Sites / Locations
- Specialty Surgery of Fort Worth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Stoma Adjustment at Surgery
Historic
Arm Description
The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery. EndoFLIP device (FDA Device Listing Number : D091203)will be used to make the adjustment.
Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records. Band adjustments are made in a heuristic fashion during the year after surgery using the experience of surgeon alone
Outcomes
Primary Outcome Measures
%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)
%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)
% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)
% Excess Weight Loss 12 Months After Surgery (Small Bands Only)
Secondary Outcome Measures
Number of Band Adjustments Required in the First Year After Surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01060592
Brief Title
LapBand Adjustment to Improve Early Weight Loss
Official Title
Effect on Early Weight Loss by Adjusting Gastric Band During Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crospon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Gastric Band, LapBand, Bariatric Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stoma Adjustment at Surgery
Arm Type
Experimental
Arm Description
The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery. EndoFLIP device (FDA Device Listing Number : D091203)will be used to make the adjustment.
Arm Title
Historic
Arm Type
No Intervention
Arm Description
Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records. Band adjustments are made in a heuristic fashion during the year after surgery using the experience of surgeon alone
Intervention Type
Device
Intervention Name(s)
EndoFLIP device (FDA Device Listing Number : D091203)
Intervention Description
The EndoFLIP balloon catheter will be introduced to the band and used to permit the band stoma size to be adjusted to 7mm.
Primary Outcome Measure Information:
Title
%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)
Time Frame
4-6 weeks post surgery
Title
%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)
Time Frame
4-6 weeks post surgery
Title
% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)
Time Frame
12m post surgery
Title
% Excess Weight Loss 12 Months After Surgery (Small Bands Only)
Time Frame
12m post surgery
Secondary Outcome Measure Information:
Title
Number of Band Adjustments Required in the First Year After Surgery
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing gastric band surgery
Over 18 years of age
Exclusion Criteria:
Actively bleeding varices
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Snow, DO FACOS
Organizational Affiliation
AIGB
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John O'Dea, PhD
Organizational Affiliation
Crospon
Official's Role
Study Director
Facility Information:
Facility Name
Specialty Surgery of Fort Worth
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Snow RG, O'Dea J. Does Intraoperative Gastric Band Adjustment to a Targeted Stoma Size Improve Weight Loss? One-year Results of a Feasibility Trial Bariatric Times. 2012;9(1):10-12.
Results Reference
result
Learn more about this trial
LapBand Adjustment to Improve Early Weight Loss
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