We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679848
First Posted: May 19, 2008
Last Update Posted: January 11, 2017
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.
Information provided by (Responsible Party):
C. R. Bard
  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: 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

Resource links provided by NLM:


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

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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00679848     History of Changes
Other Study ID Numbers: DVL-EC-003
First Submitted: May 13, 2008
First Posted: May 19, 2008
Last Update Posted: January 11, 2017
Last Verified: January 2017

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