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A Prospective, Clinical Trial of the TANTALUS® System in Treatment of Obese to Morbidly Obese Patients

NCT00779363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-09-22

No results posted yet for this study

Summary

The objectives of this feasibility study are to evaluate the safety and functionality of the TANTALUS System with TANTALUS II IPG, to assess the effect of GCM signal application on trends of HbA1c, blood glucose and body weight changes.

Conditions

Interventions

DEVICE

rechargeable TANTALUS II

Subjects will undergo an approximately two week baseline screening process. Eligible subjects will undergo device implantation. This will be followed by therapy initiation approximately one week after implantation. The device will then be activated to automatically deliver gastric contractility modulating (GCM) for 12 weeks of therapy. Stimulation will continue in for a safety monitoring period of 18 months following the therapy period.

Sponsors & Collaborators

  • MetaCure (USA), Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-06-30
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 NCT00779363 on ClinicalTrials.gov