Transoral Gastric Volume Reduction as an Intervention for Weight Management (TRIM)

C. R. Bard

Status and phase

Completed

Phase 1

Conditions

Obesity

Treatments

Device: RS2 (RESTORe Suturing System)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00679848

DVL-EC-003

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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