Evaluation of the Tantalus System in Type 2 Diabetic Subjects
Metacure MC PT TAN2005-013 feasibility study is a prospective, multi-center, study to evaluate the safety and functionality of the TANTALUS System, in the treatment of obese T2DM patients, and to assess the effect of GCT ( Glycemic Control Treatment )on weight loss and glycemic control.
Type 2 Diabetes
Device: Implantable pulse generator and electrodes
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Tantalus System in Type 2 Diabetic Subjects|
- Evaluation of the of device and/or procedure related adverse events
- Evaluation of blood chemistry, hematology and urinalysis
- Ability to record electrical activity from the stomach
- Ability to communicate between patient wand and the device.
- Significant decrease in the HbA1c values between baseline and end-of-treatment
- Reduction in the required medications due to improved glycemia.
- Significant reduction in weight loss between baseline and end-of-treatment
- Improvement in co-morbid parameters
|Study Start Date:||December 2005|
|Study Completion Date:||June 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
|Allgemeinen Krankenhauses der Stadt Wein AkH|
|Vienna, Austria, 1090|
|Principal Investigator:||Bernhard Ludvik, Prof.||Allgemeinen Krankenhauses der Stadt Wein AkH|