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LapBand Adjustment to Improve Early Weight Loss

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crospon
ClinicalTrials.gov Identifier:
NCT01060592
First received: January 30, 2010
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Obesity
Device: EndoFLIP device (FDA Device Listing Number : D091203)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect on Early Weight Loss by Adjusting Gastric Band During Surgery

Resource links provided by NLM:


Further study details as provided by Crospon:

Primary Outcome Measures:
  • %Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands) [ Time Frame: 4-6 weeks post surgery ] [ Designated as safety issue: No ]
  • %Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only) [ Time Frame: 4-6 weeks post surgery ] [ Designated as safety issue: No ]
  • % Excess Weight Loss 12 Months After Surgery (Large and Small Bands) [ Time Frame: 12m post surgery ] [ Designated as safety issue: No ]
  • % Excess Weight Loss 12 Months After Surgery (Small Bands Only) [ Time Frame: 12m post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Band Adjustments Required in the First Year After Surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Actively bleeding varices
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Crospon
ClinicalTrials.gov Identifier: NCT01060592     History of Changes
Other Study ID Numbers: 2009-02
Study First Received: January 30, 2010
Results First Received: February 20, 2013
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Crospon:
Gastric Band
LapBand
Bariatric Surgery

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

ClinicalTrials.gov processed this record on November 25, 2014