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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: Clinical Trial Phase 4 study, sponsored by Columbia University.
NCT00556166 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Data was not analyzed because PI left institution and terminated the study early.
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 |
Why NCT00556166 stopped before completion
NCT00556166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Enterra Therapy Gastric Stimulator is the first listed.
NCT00556166 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00556166's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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