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
PHASE2
17 participants
INTERVENTIONAL
2012-02-29
2016-06-30
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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Band/Plication
Treatment -- band/plication
Plication
Plication of the stomach will be performed in conjunction with placement of a gastric band.
Interventions
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Plication
Plication of the stomach will be performed in conjunction with placement of a gastric band.
Eligibility Criteria
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Inclusion Criteria
* BMI \> or = to 30 and co-morbid conditions or BMI \> or = to 40
* Ability to provide informed consent
* Willingness to commit to long-term follow-up
Exclusion Criteria
* Presence of metabolic or medically correctable cause(s) for obesity, such as untreated hypothyroidism or Prader-Willi
* Contraindications to surgery such as myocardial infarction within last 6 months, end stage renal or liver disease, current infection, or other disease states contraindicative to surgery, in the principal investigator's opinion
* Pregnancy
* Plan to become pregnant within two years post-surgery
* Current addiction to drugs or alcohol
* Previous history of any type of bariatric surgery (de novo group only)
* Hiatal hernia \> 3 cm
18 Years
70 Years
ALL
No
Sponsors
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Ohio State University
OTHER
Responsible Party
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Bradley Needleman
Associate Professor
Principal Investigators
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Bradley J Needleman, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Countries
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References
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Chaudhry UI, Osayi SN, Suzo AJ, Noria SF, Mikami DJ, Needleman BJ. Laparoscopic adjustable gastric banded plication: case-matched study from a single U.S. center. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):119-24. doi: 10.1016/j.soard.2014.05.030. Epub 2014 Jun 4.
Other Identifiers
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2012H0003
Identifier Type: -
Identifier Source: org_study_id
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