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The TANTALUS® II System for the Treatment of Type 2 Diabetes: A Randomized Study

NCT00547482 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2010-12-16

No results posted yet for this study

Summary

The main purpose of this research study is to investigate whether the TANTALUS II System is effective in improving glycemic (blood sugar) control in subjects who have type 2 diabetes (high blood sugar) and are overweight. The research will also evaluate the impact on weight loss and will study other health conditions related to obesity.

This research study involves an experimental system. The experimental system is the TANTALUS System, which consists of the implantable portion that includes the implantable pulse generator (IPG) and three pairs of implantable leads. There are also three external parts (items that are used outside your body): the programmer, the charger, and the Patient Wand.

Conditions

Interventions

DEVICE

TANTALUS(TM) System

All subjects will be implanted with the TANTALUS System (IPG with Charge Coil and UltraFlex leads) and randomized into either the "Treatment Group" or "Control Group" after surgery at Week 1, Visit 5 (device activation).

Sponsors & Collaborators

  • MetaCure (USA), Inc.

    lead INDUSTRY

Principal Investigators

  • Harold Lebowitz, MD · Professor of Medicine, Endocrinology and Metabolism/Diabetes, State University of NY Health Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00547482 on ClinicalTrials.gov