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LapBand Adjustment to Improve Early Weight Loss

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ClinicalTrials.gov Identifier: NCT01060592
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : April 4, 2013
Last Update Posted : April 8, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Device: EndoFLIP device (FDA Device Listing Number : D091203) Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect on Early Weight Loss by Adjusting Gastric Band During Surgery
Study Start Date : October 2009
Primary Completion Date : December 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stoma Adjustment at Surgery
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.
Device: EndoFLIP device (FDA Device Listing Number : D091203)
The EndoFLIP balloon catheter will be introduced to the band and used to permit the band stoma size to be adjusted to 7mm.
No Intervention: Historic
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



Primary Outcome Measures :
  1. %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) [ Time Frame: 4-6 weeks post surgery ]
  2. %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only) [ Time Frame: 4-6 weeks post surgery ]
  3. % Excess Weight Loss 12 Months After Surgery (Large and Small Bands) [ Time Frame: 12m post surgery ]
  4. % Excess Weight Loss 12 Months After Surgery (Small Bands Only) [ Time Frame: 12m post surgery ]

Secondary Outcome Measures :
  1. Number of Band Adjustments Required in the First Year After Surgery [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Actively bleeding varices

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060592


Locations
United States, Texas
Specialty Surgery of Fort Worth
Hurst, Texas, United States, 76054
Sponsors and Collaborators
Crospon
Investigators
Principal Investigator: Robert G Snow, DO FACOS AIGB
Study Director: John O'Dea, PhD Crospon

Publications:
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.

Responsible Party: Crospon
ClinicalTrials.gov Identifier: NCT01060592     History of Changes
Other Study ID Numbers: 2009-02
First Posted: February 2, 2010    Key Record Dates
Results First Posted: April 4, 2013
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Crospon:
Gastric Band
LapBand
Bariatric Surgery

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms