Obesity Clinical Trial
Official title:
A Prospective Clinical Trial of the TANTALUS System In Treatment of Obese to Morbidly Obese Patients
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.
This is a prospective multi center, non-randomized, treatment only clinical trial with up to
thirty (30) obese with type 2 diabetes subjects. The study is designed to demonstrate that
use of the rechargeable TANTALUS II IPG is safe and that it functions as designed.
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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