Status:
COMPLETED
Evaluation of the Tantalus System in Type 2 Diabetic Subjects
Lead Sponsor:
MetaCure Limited
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
21-60 years
Phase:
PHASE1
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 asse...
Eligibility Criteria
Inclusion
- T2DM subjects inadequately controlled on a maximum of three oral agents
- Subjects with HbA1c between 7 and 9%
- Subjects with FBG between 120 and 200 mg/dL
- Subjects who are 21-60 years old
- 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
- Subjects with Body Mass Index (BMI) between 30-38 (inclusive)
- Subjects with waist circumference \>94 cm (males) and \>80 cm (females)
- Subjects on stable medication program for at least three months with any oral medication program
- Subjects who are compliant, willing and able to participate in the follow-up visits for the study duration of approximately 26 weeks
- 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.
- Able to provide voluntary informed consent.
Exclusion
- Subjects at high risk of general anesthesia or surgery
- Subjects with prior pancreatitis
- Subjects with chronic hepatitis
- Subjects with elevated serum creatinine
- Subjects with proliferative diabetic retinopathy
- Subjects with gastroparesis or intestinal pseudo-obstruction
- Subjects with motility disorders of the GI tract
- Subjects who are receiving medications known to affect gastric motility
- Subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures
- Subjects who are pregnant (proven by positive hCG), or lactating
- Subjects who have had prior bariatric surgery
- Subjects with a history of peptic ulcer disease
- Subjects who have used another investigational device or agent in the 30 days prior to implant or are participating in any other clinical study
- Subjects with any new medical problem diagnosed or the worsening of an existing medical problem during the baseline evaluation period
- Subjects with a life-threatening co-morbidity or life expectancy of less than one year
- Subjects with myocardial infarction or one or more episodes of unstable angina within 6 months prior to enrollment
- Subjects with a history of malignant disease
- Subjects who are currently on chemotherapy treatment
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00276471
Start Date
December 1 2005
End Date
June 1 2007
Last Update
February 2 2012
Active Locations (1)
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1
Allgemeinen Krankenhauses der Stadt Wein AkH
Vienna, Austria, 1090