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Sponsored by: |
MetaCure (USA), Inc. |
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Information provided by: | MetaCure (USA), Inc. |
ClinicalTrials.gov Identifier: | NCT00547482 |
The main purpose of this research study is to investigate whether the TANTALUS II System is effective in improving glycemic (blood sugar) control in subjects who have type 2 diabetes (high blood sugar) and are overweight. The research will also evaluate the impact on weight loss and will study other health conditions related to obesity.
This research study involves an experimental system. The experimental system is the TANTALUS System, which consists of the implantable portion that includes the implantable pulse generator (IPG) and three pairs of implantable leads. There are also three external parts (items that are used outside your body): the programmer, the charger, and the Patient Wand.
Condition | Intervention |
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Type 2 Diabetes Mellitus Overweight |
Device: TANTALUS(TM) System |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study |
Enrollment: | 300 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: Sham Comparator
They will all be implanted but not activated for the Initial Study Period (24 weeks), followed by all subjects assigned to treatment (Control Group with device activation) in the Study Extension Period (an additional 24 weeks). Subjects will remain in the study (Safety Monitoring Period) with semi-annual evaluations until a determination of safety and efficacy is made by the FDA.
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Device: TANTALUS(TM) System
All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the "Treatment Group" or "Control Group" after surgery at Week 1, Visit 5 (device activation).
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Treatment: Active Comparator
All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the "Treatment Group" or "Control Group" after surgery at Week 1, Visit 5 (device activation). They will be followed for the Initial Study Period (24 weeks), followed by the Study Extension Period (an additional 24 weeks). Subjects will remain in the study (Safety Monitoring Period) with semi-annual evaluations until a determination of safety and efficacy is made by the FDA.
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Device: TANTALUS(TM) System
All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the "Treatment Group" or "Control Group" after surgery at Week 1, Visit 5 (device activation).
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This is a randomized, double-blind and controlled, multi-center study. Three hundred (300) subjects with type 2 diabetes ranging from low BMI to BMI 45 (BMI ≥ 28 and ≤ 45) will be enrolled.
The duration of subject participation in the main portion of the study which includes the initial study and study extension periods is expected to be approximately 12 months. Upon completion of this period, subjects with a TANTALUS device shall continue to be followed clinically at six-month intervals (Safety Monitoring Period) until the FDA has made a determination regarding the safety and efficacy of the device.
Ages Eligible for Study: | 18 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 | |
Scripps Clinic Del Mar | |
La Jolla / San Diego, California, United States, 92130 | |
United States, Colorado | |
University of Colorado at Denver Health Sciences Center | |
Denver, Colorado, United States, 80262 | |
United States, Missouri | |
Washington University School of Medicine in St. Louis | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Kaleida Health, Diabetes-Endocrinology Center of Western New York | |
Buffalo, New York, United States, 14209 | |
Comprehensive Weight Control Program Cornell Medical Center | |
New York, New York, United States, 10021 | |
Mt. Sinai School of Medicine | |
NY, New York, United States, 10029-6574 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Pennsylvania, Pennsylvania, United States, 19104-3309 | |
United States, Tennessee | |
Vanderbilt University School of Medicine | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Diabetes and Glandular Disease Clinic (DGD) | |
San Antonio, Texas, United States, 78229 |
Study Chair: | Harold Lebowitz, MD | Professor of Medicine, Endocrinology and Metabolism/Diabetes, State University of NY Health Science |
Responsible Party: | MetaCure (USA), Iinc. ( MetaCure (USA) Inc. ) |
Study ID Numbers: | MC CR TAN2006-067 |
Study First Received: | October 4, 2007 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00547482 |
Health Authority: | United States: Food and Drug Administration |
Type 2 Diabetes Overweight Obese |
Body Weight Signs and Symptoms Obesity Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Overweight Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |