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The TANTALUS® II for the Treatment of Type 2 Diabetes

NCT01303302 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2016-09-22

No results posted yet for this study

Summary

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

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

Tantalus System

The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes

DEVICE

TANTALUS system

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.

Sponsors & Collaborators

  • MetaCure (USA), Inc.

    lead INDUSTRY

Principal Investigators

  • Walid Hadda, PhD · MetaCure Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Austria
  • Germany
  • Italy
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303302 on ClinicalTrials.gov