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Evaluation of the Tantalus System in Type 2 Diabetic Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00276471
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : February 2, 2012
Sponsor:
Information provided by:
Metacure

Tracking Information
First Submitted Date  ICMJE January 12, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date February 2, 2012
Study Start Date  ICMJE December 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2006)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
  • 1)Evaluation of the of device and/or procedure related adverse events
  • 2)Evaluation of blood chemistry, hematology and urinalysis
  • 3) Ability to record electrical activity from the stomach
  • 4) Ability to communicate between patient wand and the device.
Change History Complete list of historical versions of study NCT00276471 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
  • 1)Significant decrease in the HbA1c values between baseline and end-of–treatment
  • 2)Reduction in the required medications due to improved glycemia.
  • 3)Significant reduction in weight loss between baseline and end-of-treatment
  • 4) Improvement in co-morbid parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Tantalus System in Type 2 Diabetic Subjects
Official Title  ICMJE Evaluation of the Tantalus System in Type 2 Diabetic Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes
  • Obesity
Intervention  ICMJE Device: Implantable pulse generator and electrodes
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 12, 2006)
18
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276471
Other Study ID Numbers  ICMJE MC PT TAN2005-013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Metacure
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bernhard Ludvik, Prof. Allgemeinen Krankenhauses der Stadt Wein AkH
PRS Account Metacure
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP