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NCT00157755 · ClinicalTrials.gov registry record · NA
Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)
A NA study, sponsored by MedtronicNeuro.
- Terminated
- Registry status
- NA
- Development phase
- 87
- Enrollment target
NCT00157755: Clinical Trial NA study, sponsored by MedtronicNeuro.
NCT00157755 is a NA study that was terminated before completion, run by MedtronicNeuro. The registered enrollment target is 87 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00157755, a NA study, was terminated before completion, sponsored by MedtronicNeuro.
- TERMINATED
- Registry status
- NA
- Development phase
- 87 participants
- Enrollment target
Study Summary
This study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis using an approved Humanitarian device. There are two cohorts in this study based on etiology, one for diabetic and one for idiopathic. A maximum of 150 patients (75 diabetic and 75 idiopathic) from up to 15 centers in the United States will be followed closely for twelve months and then once a year after that until the study closes. If you are someone suffering with symptoms of gastroparesis despite trying oral medications, you may be eligible to participate in a clinical study using a surgically implanted gastric stimulator.
Primary Outcome
Diaries were used to record daily vomiting episodes for 28 days prior to each office follow-up visit. The weekly vomiting frequency (WVF) was based on the average number of weekly vomiting episodes recorded in the patient diary. The percent reduction is calculated as ((WVF during OFF - WVF during ON)/ (WVF during OFF))\*100%. A positive reduction represents an improvement in WVF when the device was ON.
Interventions
- DEVICE Enterra Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2002-06 |
| Est. Completion | 2009-03 |
| Phase | NA |
Why NCT00157755 stopped before completion
NCT00157755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Enterra Therapy is the first listed.
NCT00157755 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00157755 about?
NCT00157755 is a clinical study titled "Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)". This study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis using an approved Humanitarian device. There are two cohorts in this study based on etiology, one for diabetic and one for idiopathic. A maximum of 15...
What is the current status of trial NCT00157755?
This trial is currently terminated. It is a NA study. The enrollment target is 87 participants. The study started on 2002-06. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00157755?
The interventions under investigation include: Enterra Therapy (DEVICE).
Who is sponsoring clinical trial NCT00157755?
This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00157755's enrollment target sits among peer trials
87 974th of 2000 higher than 1,025 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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