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

This study has been completed.
Sponsor:
Information provided by:
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00679848
First received: May 13, 2008
Last updated: August 3, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Obesity
Device: RS2 (RESTORe Suturing System)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Technical success of test procedure. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: May 2008
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Transoral Suturing
Device: RS2 (RESTORe Suturing System)
Suturing in stomach

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679848

Locations
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
  More Information

No publications provided

Responsible Party: Tom Hutchinson, Davol
ClinicalTrials.gov Identifier: NCT00679848     History of Changes
Other Study ID Numbers: DVL-EC-003
Study First Received: May 13, 2008
Last Updated: August 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by C. R. Bard:
Weight Loss
Transoral Suturing
Experimental

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014