Transoral Gastric Volume Reduction as an Intervention for Weight Management

Phase 1

Completed

• Conditions: Obesity
• Interventions: Device: RS2 (RESTORe Suturing System)

• Registration Number: NCT00679848
• Lead Sponsor: C. R. Bard

Brief Summary

The purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR performed using the Bard RESTORe Suturing System

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-13
• Study First Submitted QC: 2008-05-15
• Study First Posted: 2008-05-19
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-09
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Male, Female; ages >18yrs - £ 60 yrs
• BMI 30-45 kg/m2
• History of obesity for 5 yrs; attempts at weight control ineffective
• Weight stable
• Willing to comply with study requirements
• Agrees to not have any additional weight loss surgery, reconstructive surgery or liposuction for one year following procedure
• Sign informed consent form

Exclusion Criteria

• Women of childbearing age not practicing effective birth control method or pregnant or lactating
• Mallampati score = 4
• Uncontrolled hypothyroidism
• Previous interventional/surgical treatment of obesity; any prior gastric surgery
• History of diabetes for > 10 yrs or difficult to control diabetes
• Presence of hiatal hernia
• Congenital or acquired anomalies of the GI tract
• Severe cardiovascular, cerebrovascular, or cardiopulmonary disease
• Chronic or acute upper gastrointestinal bleeding conditions
• Helicobacter pylori positive
• Immunocompromised
• Subjects with eating disorders
• Acute or chronic infection
• Significant movement limitations
• Not a candidate for conscious or general anesthesia
• Active substance abuse
• Life expectancy < 2 years
• Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	RS2 (RESTORe Suturing System)	Transoral Suturing

Primary Outcome Measures

Name	Time	Method
Weight Loss	24 Months

Secondary Outcome Measures

Name	Time	Method
Technical success of test procedure.	24 months

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States