Enterra Therapy Gastric Stimulation System
Enterra Therapy Gastric Simulation System (Enterra Therapy) is indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis of diabetic or idiopathic origin.
In March 2000, the Food and Drug Administration (FDA) gave approval of a humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD) for Enterra Therapy Gastric electrical (GES) Simulation System. Although, there is evidence that suggests the use of Enterra Therapy System probably helps patients, symptoms, the FDA's HDE approval indicates that the helpfulness of this therapy has not been proven.
Physicians at Columbia University Medical Center hope to prove the helpfulness of this device.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Enterra Therapy Gastric Stimulation System|
- Incidence of number of episodes of nausea and vomiting. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Incidence in number of episodes of abdominal pain, bloating, and early satiety. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Subjects enrolled in this study have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
Device: Enterra Therapy Gastric Stimulator
The intramuscular stomach leads, implanted in a minimally invasive surgical procedure lasting 1-3 hours, are placed on the greater curvature of the stomach. The implanted pulse generator (IPG) is about 2 1/2" x 2" x 1/2" and is implanted in a subcutaneous pocket, generally created in the abdominal area, and is then connected to the leads. The IPG provides the energy source that delivers the electrical pulse to the stomach muscle through the stomach leads to improve the symptoms of gastroparesis.
The doctor will use an external programmer to change the settings of the neurostimulator and control the neurostimulator after implantation. Part of the programmer is held outside the body over the implant site and can adjust or change the settings of the neurostimulator using radio remote control.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556166
|United States, New York|
|Columbia University College of Physicians and Surgeons|
|New York, New York, United States, 10032|
|Principal Investigator:||Dennis L. Fowler, M.D.||Columbia University College of Physicians and Surgeons|