Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2009-07-31
2012-03-31
Brief Summary
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Detailed Description
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Materials and Methods:
Adults ≥ 18 years of age who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate. Patients of both genders and all races are eligible for participation. Patients will need to consent to complete a questionnaire and to have blood drawn when the band is loosened and refilled. Patients will only be excluded if they are not willing to have their band loosened or if they will not present for follow-up.
Sample size:
For this pilot program we plan to enroll 15 patients. Since patients will serve as their own controls before and after meals as well as before and after band adjustments, we anticipate adequate power to assess for significant variations.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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No Arm
Band adjustment and specimen collection
Clinical evaluation and sample collection before and after band adjustment
Interventions
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Band adjustment and specimen collection
Clinical evaluation and sample collection before and after band adjustment
Eligibility Criteria
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Inclusion Criteria
* who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and
* agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Heekoung A Youn
Research coordinator
Principal Investigators
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Francois Fritz, M.D.
Role: PRINCIPAL_INVESTIGATOR
NYUSOM
Locations
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NYUSOM
New York, New York, United States
Countries
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Other Identifiers
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NYUSWLP-BH
Identifier Type: -
Identifier Source: org_study_id