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Completed

NCT Number: NCT00679848

Transoral Gastric Volume Reduction as an Intervention for Weight Management

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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RS2 (RESTORe Suturing System)

Device

Suturing in stomach

Primary outcomes

  1. Weight Loss

    Time frame: 24 Months

Secondary outcomes

  1. Technical success of test procedure.

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study 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

Acronym: TRIM

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 19, 2008
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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