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Category Archives: Clinical Trial

Novel Gastrointestinal Interventional Therapies > Endolumenal application > GI Dynamics > Gut-Lining Device > Combats Diabetes > Obesity Clinical Trial > Reduced blood sugar > More invasive procedures might carry more risk > Harvard Medical School > Reversible > Device can be retrieved via the mouth > First World Congress on Interventional Therapies for Type 2 Diabetes > EndoBarrier Gastrointestinal Liner Data > Patients with Type 2 Diabetes > Presented at the First World Congress > Interventional Therapies for Type 2 Diabetes

Thursday, September 18, 2008

Has the EndoBarrier potential to provide immediate metabolic control with less risk? Are these the most exciting and promising device data from endoscopic devices? Has this disease has reached epidemic proportions around the globe? Is there a substantial unmet need for a simple and safe approach for patients to achieve metabolic control?

IIP > read on […]

Filed in Prospective randomized sham-controlled clinical trial, Clinical-stage medical device company, Deliver immediate metabolic control, Modifying metabolic pathways, Endoluminal Therapies for Type 2 Diabetes, Keynote lecture, Novel Gastrointestinal Interventional Therapies, Lee M Kaplan, Weight Center, Orally delivered, Removable device, Health policy makers, Public health authorities and insurers, Seize the opportunity, Novel interventional therapies, Forum for the medical community, Comprehensive and multidisciplinary forum, Lines a portion of the small intestine, Top-tier investors, Catalyst Health Ventures, Treat obesity and type 2 diabetes, Noninvasive device, Domain Associates, Johnson & Johnson Development Corporation, Polaris Venture Partners, Bariatric surgery, Cutlass Capital, Advanced Technology Ventures, New York Presbyterian Hospital, Weill Cornell Medical College, GI Dynamics, Type 2 diabetes, Clinical Trial, Patients with Type 2 Diabetes, First World Congress on Interventional Therapies, Pioneering new approaches to treating metabolic disorde, Medical Device Company, EndoBarrier Gastrointestinal Liner, Gastrointestinal surgery, Resulting in weight loss, Improved glycemic control, Massachusetts General Hospital | Comments Off

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