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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00679848
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : January 11, 2017
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Obesity Device: RS2 (RESTORe Suturing System) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transoral Gastric Volume Reduction as an Intervention for Weight Management (TRIM): A Non-Randomized Multicenter Feasibility Study of Subjects With Class II or Low Grade Class III Obesity
Study Start Date : May 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Transoral Suturing
Device: RS2 (RESTORe Suturing System)
Suturing in stomach

Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  1. Technical success of test procedure. [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00679848

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
C. R. Bard
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Responsible Party: C. R. Bard Identifier: NCT00679848    
Other Study ID Numbers: DVL-EC-003
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Keywords provided by C. R. Bard:
Weight Loss
Transoral Suturing
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight