Transoral Gastric Volume Reduction as an Intervention for Weight Management
NCT ID: NCT00679848
Last Updated: 2017-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2008-05-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Transoral Suturing
RS2 (RESTORe Suturing System)
Suturing in stomach
Interventions
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RS2 (RESTORe Suturing System)
Suturing in stomach
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Other Identifiers
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DVL-EC-003
Identifier Type: -
Identifier Source: org_study_id
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