Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2007-04-23
2016-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gastric Banding
Surgical placement of an adjustable gastric band around the upper portion of the stomach.
Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
Adjustable Gastric Band
Surgical placement of an adjustable gastric band around the upper portion of the stomach.
Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
Interventions
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Adjustable Gastric Band
Surgical placement of an adjustable gastric band around the upper portion of the stomach.
Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI \> 35
* history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months.
* confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.
Exclusion Criteria
* history of esophageal motility disorders
* uncontrolled psychiatric problems
* previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis.
* uncontrolled eating disorders
14 Years
19 Years
ALL
No
Sponsors
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Kirk Reichard
OTHER
Responsible Party
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Kirk Reichard
OR SURGICAL DIRECTOR
Principal Investigators
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Kirk Reichard, MD
Role: PRINCIPAL_INVESTIGATOR
A I duPont Hospital for Children; Nemours Children's Clinic
Locations
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A I duPont Hospital for Children/Nemours Children's Clinic
Wilmington, Delaware, United States
Countries
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Other Identifiers
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0082295
Identifier Type: -
Identifier Source: org_study_id
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