Clinical Trials Directory

Trials / Completed

CompletedNCT00721227

Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Ethicon Endo-Surgery · Industry
Sex
All
Age
21 Years – 60 Years
Healthy volunteers
Not accepted

Summary

This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention.

Detailed description

The overall plan for all subjects consists of the following elements: * Subject will be informed about the nature of the research, given the Informed Consent Document (ICD) to read, and if the subject understands and agrees to the procedure will be asked to sign a written informed consent (the ICD). * Subjects will undergo reduction gastroplasty by gastric plication in which a section of the stomach will be infolded by multiple rows of sutures. * Subjects are followed for 12 months to evaluate outcomes and potential complications.

Conditions

Interventions

TypeNameDescription
PROCEDUREReduction Gastroplasty* Subjects will undergo reduction gastroplasty by gastric plication * Subjects are followed for 12 months to evaluate outcomes and potential complications.

Timeline

Start date
2008-04-01
Primary completion
2010-03-01
Completion
2010-03-01
First posted
2008-07-24
Last updated
2010-09-08
Results posted
2010-08-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00721227. Inclusion in this directory is not an endorsement.