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NCT00556166 · ClinicalTrials.gov registry record · Phase 4
Enterra Therapy Gastric Stimulation System
A Phase 4 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT00556166 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 4 participants.
The verdict
NCT00556166, a Phase 4 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Enterra Therapy Gastric Stimulator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2004-10 |
| Est. Completion | 2008-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00556166
The ClinicalTrials.gov registry entry for NCT00556166 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enterra Therapy Gastric Stimulator is the first listed.
NCT00556166 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00556166 about?
NCT00556166 is a clinical study titled "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...
What is the current status of trial NCT00556166?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2004-10. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00556166?
The interventions under investigation include: Enterra Therapy Gastric Stimulator (DEVICE).
Who is sponsoring clinical trial NCT00556166?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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