Enterra Therapy Gastric Stimulation System
Stopped early · Phase 4
Conditions studied: Gastroparesis
In brief
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.
Key facts
- Study ID
- NCT00556166
- Run by
- Columbia University
- People needed
- 4
- Starts
- 2004-10-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2016-08-02
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Chronic(long term, lasting greater than 3 months)
- Intractable (drug refractory, failed medical management with prokinetic and antiemetic drugs
- Failed dietary modifications, and/or requiring enteral feeding) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology
You may not qualify if…
- Only patients whom the physician determines are not a candidate for surgical procedures and/or anesthesia due to physical or mental conditions will be excluded. This includes pregnant women, anyone unable to tolerate general anesthesia, and uncorrectable coagulopathy.
Where it is running
- Columbia University College of Physicians and Surgeons — New York, New York, United States
Full record on ClinicalTrials.gov
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