Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Ethicon Endo-Surgery |
---|---|
Information provided by: | Ethicon Endo-Surgery |
ClinicalTrials.gov Identifier: | NCT00721227 |
This trial will assess the feasibility of reduction gastroplasty with standard suture in bariatric patients who are candidates for surgical weight loss intervention.
Condition | Intervention |
---|---|
Obesity |
Procedure: Reduction Gastroplasty |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Assessment of Gastric Volume Reduction in Surgical Weight Loss Candidates |
Estimated Enrollment: | 10 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A
Reduction Gastroplasty by Gastric Plication
|
Procedure: Reduction Gastroplasty
|
The overall plan for all subjects consists of the following elements:
Ages Eligible for Study: | 21 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects are considered appropriate candidates for the study if they fulfill the following criteria:
Exclusion Criteria:
Subjects will be excluded from the study for any of the following:
Any condition which precludes compliance with the study, including:
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | Philip R Schauer, M.D | Cleveland Clinic |
Responsible Party: | Ethicon Endo-Surgery ( Susan Knippenberg ) |
Study ID Numbers: | CI-07-0005 |
Study First Received: | July 9, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00721227 |
Health Authority: | United States: Institutional Review Board |
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overweight Overnutrition |