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NCT00200057 · ClinicalTrials.gov registry record · NA
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
A NA study, sponsored by MedtronicNeuro.
- Completed
- Registry status
- NA
- Development phase
- 285
- Enrollment target
NCT00200057 is a NA study that has completed, run by MedtronicNeuro. The registered enrollment target is 285 participants.
The verdict
NCT00200057, a NA study, has completed, sponsored by MedtronicNeuro.
- COMPLETED
- Registry status
- NA
- Development phase
- 285 participants
- Enrollment target
Study Summary
Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool until an acceptable time and place). FI is not a life-threatening disease, but it is often profoundly distressing and socially incapacitating. If a patient is suffering with symptoms of chronic FI despite trying oral medications, biofeedback and/or other more conservative treatments, a patient may be eligible to participate in a clinical research study to evaluate the safety and effectiveness of sacral nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120) patients will be implanted with medical devices and followed closely for twelve months, and then once a year after that until the study closes. There are up to 20 centers in the United States.
Interventions
- DEVICE InterStim Sacral Nerve Stimulation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 285 participants |
| Start Date | 2002-01 |
| Est. Completion | 2011-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00200057
The ClinicalTrials.gov registry entry for NCT00200057 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 285 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MedtronicNeuro, which has 51 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which InterStim Sacral Nerve Stimulation Therapy is the first listed.
NCT00200057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00200057 about?
NCT00200057 is a clinical study titled "Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence". Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but canno...
What is the current status of trial NCT00200057?
This trial is currently completed. It is a NA study. The enrollment target is 285 participants. The study started on 2002-01. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00200057?
The interventions under investigation include: InterStim Sacral Nerve Stimulation Therapy (DEVICE).
Who is sponsoring clinical trial NCT00200057?
This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.
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