Evaluation of the Tantalus System in Type 2 Diabetic Subjects

January 31, 2012 updated by: MetaCure Limited
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Allgemeinen Krankenhauses der Stadt Wein AkH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetaCure Limited

Investigators

  • Principal Investigator: Bernhard Ludvik, Prof., Allgemeinen Krankenhauses der Stadt Wein AkH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • MC PT TAN2005-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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