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

NACompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Type 2 DiabetesObesity
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.

Trial Locations (2)

78229

Diabetes and Glandular Disease Clinic (DGD), San Antonio

90048

Cedars Sinai, Los Angeles

All Listed Sponsors
lead

MetaCure (USA), Inc.

INDUSTRY

NCT00779363 - A Prospective, Clinical Trial of the TANTALUS® System in Treatment of Obese to Morbidly Obese Patients | Biotech Hunter | Biotech Hunter