Transoral Gastric Volume Reduction as an Intervention for Weight Management

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00679848

Acronym

TRIM

Enrollment

Registered

2008-05-19

Start date

2008-05-31

Completion date

2010-11-30

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Weight Loss, Transoral Suturing, Experimental

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

Interventions

DEVICERS2 (RESTORe Suturing System)

Suturing in stomach

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Weight Loss	24 Months

Secondary

Measure	Time frame
Technical success of test procedure.	24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026