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NCT04066894 · ClinicalTrials.gov registry record · Phase 2
Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT04066894: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT04066894 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04066894, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve stimulation is a permanent implant that may improve bowel functions by stimulating the nerves that control the muscles related to bowel function.
Primary Outcome
SNS success will be measured as a patient having the battery implanted at visit 3. Patients who do not have the SNS placed, for any reason other than insurance coverage issues, will count as not having a success. Fecal incontinence will be measured by the physician as the total number of gas, mucus, liquid stool, and solid stool accidental leakage events reported in the bowel diaries. Improvement will be determined by the physician based on bowel diary comparisons recorded before SNS lead placem
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- PROCEDURE Explantation
- DEVICE Sacral Nerve Stimulator
- DEVICE Sacral Nerve Stimulator Battery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-04-12 |
| Est. Completion | 2022-09-01 |
| Phase | Phase 2 |
Why NCT04066894 stopped before completion
NCT04066894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04066894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04066894 about?
NCT04066894 is a clinical study titled "Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study". This phase II trial studies how well sacral nerve stimulation works in treating low anterior resection syndrome or fecal incontinence (the body's passage of stool without control) in patients with rectal cancer that has spread to nearby tissues or lymph nodes, or other pelvic cancer. Sacral nerve st...
What is the current status of trial NCT04066894?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2019-04-12. Estimated completion is 2022-09-01.
What interventions are being tested in trial NCT04066894?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Explantation (PROCEDURE), Sacral Nerve Stimulator (DEVICE), Sacral Nerve Stimulator Battery (DEVICE).
Who is sponsoring clinical trial NCT04066894?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04066894's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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