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Sponsored by: |
MetaCure (USA), Inc. |
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Information provided by: | MetaCure (USA), Inc. |
ClinicalTrials.gov Identifier: | NCT00779363 |
The objectives of this feasibility study are to evaluate the safety and functionality of the TANTALUS System with TANTALUS II IPG, to assess the effect of GCM signal application on trends of HbA1c, blood glucose and body weight changes.
Condition | Intervention |
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Type 2 Diabetes Obesity |
Device: rechargeable TANTALUS II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Prospective Clinical Trial of the TANTALUS System In Treatment of Obese to Morbidly Obese Patients |
Enrollment: | 14 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Implanted Device: Experimental |
Device: rechargeable TANTALUS II
Subjects will undergo an approximately two week baseline screening process. Eligible subjects will undergo device implantation. This will be followed by therapy initiation approximately one week after implantation. The device will then be activated to automatically deliver gastric contractility modulating (GCM) for 12 weeks of therapy. Stimulation will continue in for a safety monitoring period of 18 months following the therapy period.
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This is a prospective multi center, non-randomized, treatment only clinical trial with up to thirty (30) obese with type 2 diabetes subjects. The study is designed to demonstrate that use of the rechargeable TANTALUS II IPG is safe and that it functions as designed.
Subjects will undergo an approximately two week baseline screening process. Eligible subjects will undergo device implantation. This will be followed by therapy initiation approximately one week after implantation. The device will then be activated to automatically deliver gastric contractility modulating (GCM) for 12 weeks of therapy. Stimulation will continue in for a safety monitoring period of 18 months following the therapy period.
Ages Eligible for Study: | 21 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Cedars Sinai | |
Los Angeles, California, United States, 90048 | |
United States, Texas | |
Diabetes and Glandular Disease Clinic (DGD) | |
San Antonio, Texas, United States, 78229 |
Study Chair: | Harold Lebowitz, MD | Proffesor of Medicine, Endocrinology and Metabolism/Diabetes, State University on NY Health Science |
Responsible Party: | MetaCure (USA), Inc. ( MetaCure (USA), Inc. ) |
Study ID Numbers: | MC CR TAN2007-012 |
Study First Received: | October 23, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00779363 |
Health Authority: | United States: Food and Drug Administration |
obese, Diabetes |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |