Evaluation of the Tantalus System in Type 2 Diabetic Subjects
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- 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. []
Secondary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
Inclusion Criteria:
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T2DM subjects inadequately controlled on a maximum of three oral agents
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Subjects with HbA1c between 7 and 9%
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Subjects with FBG between 120 and 200 mg/dL
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Subjects who are 21-60 years old
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Women with childbearing potential (i.e. not post-menopausal or surgically sterilized) must agree to use adequate birth control methods and must agree not to conceive for at least 20 weeks
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Subjects with Body Mass Index (BMI) between 30-38 (inclusive)
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Subjects with waist circumference >94 cm (males) and >80 cm (females)
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Subjects on stable medication program for at least three months with any oral medication program
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Subjects who are compliant, willing and able to participate in the follow-up visits for the study duration of approximately 26 weeks
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Alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.
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Able to provide voluntary informed consent.
Exclusion Criteria:
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Subjects at high risk of general anesthesia or surgery
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Subjects with prior pancreatitis
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Subjects with chronic hepatitis
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Subjects with elevated serum creatinine
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Subjects with proliferative diabetic retinopathy
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Subjects with gastroparesis or intestinal pseudo-obstruction
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Subjects with motility disorders of the GI tract
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Subjects who are receiving medications known to affect gastric motility
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Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures
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Subjects who are pregnant (proven by positive hCG), or lactating
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Subjects who have had prior bariatric surgery
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Subjects with a history of peptic ulcer disease
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Subjects who have used another investigational device or agent in the 30 days prior to implant or are participating in any other clinical study
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Subjects with any new medical problem diagnosed or the worsening of an existing medical problem during the baseline evaluation period
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Subjects with a life-threatening co-morbidity or life expectancy of less than one year
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Subjects with myocardial infarction or one or more episodes of unstable angina within 6 months prior to enrollment
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Subjects with a history of malignant disease
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Subjects who are currently on chemotherapy treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Allgemeinen Krankenhauses der Stadt Wein AkH | Vienna | Austria | 1090 |
Sponsors and Collaborators
- MetaCure Limited
Investigators
- Principal Investigator: Bernhard Ludvik, Prof., Allgemeinen Krankenhauses der Stadt Wein AkH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MC PT TAN2005-013