Transoral Gastric Volume Reduction as an Intervention for Weight Management

NCT00679848 | Completed Phase 1

• 1 other identifier: DVL-EC-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Conditions

Obesity

Keywords

Weight Loss; Transoral Suturing; Experimental

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  24 Months

Secondary Outcomes (1)

• Technical success of test procedure.

  24 months

Study Arms (1)

1

EXPERIMENTAL

Transoral Suturing

Device: RS2 (RESTORe Suturing System)

Interventions

RS2 (RESTORe Suturing System) DEVICE

Suturing in stomach

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2008
• First Posted: May 19, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

US (2)