Gastroparesis Clinical Trial
— EnterraOfficial title:
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Columbia University College of Physicians and Surgeons | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of episodes of nausea and vomiting | 1 year | No | |
Secondary | Number of episodes of abdominal pain, bloating, and early satiety | 1 year | No |
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