Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
35 participants
INTERVENTIONAL
2009-10-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Over 18 years of age
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Crospon
INDUSTRY
Responsible Party
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Principal Investigators
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Robert G Snow, DO FACOS
Role: PRINCIPAL_INVESTIGATOR
AIGB
John O'Dea, PhD
Role: STUDY_DIRECTOR
Crospon
Locations
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Specialty Surgery of Fort Worth
Hurst, Texas, United States
Countries
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References
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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.
Other Identifiers
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2009-02
Identifier Type: -
Identifier Source: org_study_id
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