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| ID | Type | Description | Link |
|---|---|---|---|
| Cross-over | Other Identifier | MetaCure (USA) |
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Evaluation of the safety and efficacy of gastric contractility modulation (GCM) stimulation using the TANTALUS System in the improvement of glycemic control measured by changes in HbA1c. Effects of GCM on weight loss and associated co-morbid conditions will also be evaluated
This is a multi-center, single blind, randomized, cross-over study. Subject enrollment will continue until forty (40) eligible participants have been randomized into one of the two groups. Subjects will undergo baseline valuation (Visit 1) during which the stability of their glycemic parameters, medical treatment and medical condition will be assessed. Subjects meeting all inclusion/exclusion criteria at Visit 2 will be implanted. Approximately three days prior to their implantation, subjects will be seen for their 'pre-implant' medical evaluation (Visit 3). One week after implant (Visit 5, Week 1)subjects will be randomized into one of two groups (A and B).
"Group A" subjects will have their device programmed to deliver GCM signal including the setting of automatic eating detection parameters for the first 24 week period (Period 1). At Visit 10, (week 25 and end of Period 1), Group A subjects will have their devices turned "OFF" for the next 24 weeks period (Period 2). At Visit 15, (week 49 and end of Period 2), Group A subjects will have their devices turned "On" for the next 24 weeks period (Period 3) "Group B" subjects will not have their device activated for the first 24 weeks (Period 1) of their study. At Visit 10 (week 25 end of Period 1), Group B subjects devices will have their device turned "ON" (i.e. activated to deliver CGM signals) for the 24 weeks period (Period 2). At Visit 15, (week 49 and end of Period 2), Group B subjects will have their devices turned "OFF" for the next 24 weeks period (Period 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GCM stimulation | Active Comparator | The patient will be implanted with a gastric contractility modulation (GCM) stimulation system using the TANTALUS System for treatment of type 2 diabetic patients. |
|
| Device off | Sham Comparator | The TANTALUS System is implanted but is off |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tantalus System | Device | The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the differences in HbA1c levels | Comparison of the differences in HbA1c levels between treatment and control groups between changes occurred during period 2 to period 3 | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in weigth and metabolic parameters |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walid Hadda, PhD | MetaCure Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | ||||
| Gemeinschaftspraxis Drs. Klausmann |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| TANTALUS system | Device | The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes. In the sham comparator the device is off. |
|
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| One year |
| Aschaffenburg |
| D-63739. |
| Germany |
| Arzt für Innere Medizin und Endokrinologie | Bad Nauheim | Germany |
| Krankenhaus Sachsenhausen | Frankfurt | 60594 | Germany |
| Diabetes-Praxis Muenster | Münster | 48153 | Germany |
| Università Cattolica S. Cuore | Rome | 00168 | Italy |
| CMKP- Centrum Medyczne Kształcenia Podyplomowego | Warsaw | 01-813 | Poland |
| D004700 | Endocrine System Diseases |