Gastric Plication and Banding

Morbid Obesity Clinical Trial

— GP and Band  

Official title:

Treatment of Morbid Obesity With Gastric Plication and Gastric Banding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072395
• Other study ID #: 2012H0003
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2014
• Last updated: February 16, 2017
• Start date: February 2012
• Est. completion date: June 2016

Study information

• Verified date: February 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70

• 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:

• Inability to provide informed consent

• 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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Plication
Plication of the stomach will be performed in conjunction with placement of a gastric band.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	The primary endpoint is weight loss two years post-surgery.	Two years
Primary	Complications	Intra and post-operative complications will be tracked.	2 years