Status:
COMPLETED
Transoral Gastric Volume Reduction as an Intervention for Weight Management
Lead Sponsor:
C. R. Bard
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 B...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00679848
Start Date
May 1 2008
End Date
November 1 2010
Last Update
January 11 2017
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195