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Category Archives: Conscious or general anesthesia

RESTORe Suturing System > Patients With Class II or Low Grade Class III Obesity > Transoral Gastric Volume Reduction TGVR > Intervention for Weight Management > TRIM > C R Bard Davol > Clinical Trial

Wednesday, June 4, 2008

Is the purpose of this study is to evaluate the safety, technical feasibility, and initial effectiveness of the RESTORe Suturing System? How is Weight loss primarily measured? Can TGVR performed safely using the Bard RESTORe Suturing System?

IIP > read on here > http://clinicaltrials.gov…
Inclusion Criteria:
* Male, Female; ages >18yrs - £ 60 yrs
* BMI 30-45 kg/m2
* […]

Filed in Mallampati score = 4, Pregnant or lactating, Uncontrolled hypothyroidism, Previous interventional surgical treatment of obesity, Prior gastric surgery, Not practicing effective birth control method, Women of childbearing age, Attempts at weight control ineffective, BMI, Weight stable, Reconstructive surgery, Liposuction, Presence of hiatal hernia, Congenital or acquired anomalies of the GI tract, Active substance abuse, Conscious or general anesthesia, Life expectancy, Investigational drug or device trial, Primary endpoint, Significant movement limitations, Acute or chronic infection, Chronic or acute upper gastrointestinal bleeding condit, Severe cardiovascular cerebrovascular or cardiopulmonar, Helicobacter pylori positive, Immunocompromised, Subjects with eating disorders, Experimental, Clinical Trial, Pathological Conditions, Nutritional and Metabolic Diseases, Interventional Treatment, Non-Randomized, Open Label, MeSH terms, Signs and Symptoms, Overweight, Nutrition Disorders, Overnutrition, Primary Outcome Measures, Body Weight, Active Control, Single Group Assignment, Transoral Gastric Volume Reduction TGVR, Patients With Class II or Low Grade Class III Obesity, Intervention for Weight Management, TRIM, C R Bard Davol, RESTORe Suturing System, Suturing in stomach, Transoral Gastric Volume Reduction > Intervention fo, Safety Efficacy Study, Non-Randomized Multicenter Feasibility Study, Weight Loss, Transoral Suturing, Metabolic Diseases | Comments Off