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NCT02163187 · ClinicalTrials.gov registry record · Phase 2
Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT02163187: Clinical Trial Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02163187 is a Phase 2 study that was terminated before completion, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02163187, a Phase 2 study, was terminated before completion, sponsored by Memorial Sloan Kettering Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will help patients to have more normal bowel movements. The InterStimTM device is a neuromodulating device. Neuromodulation is a way of changing the activity of the nervous system by using electrical stimulation. InterStimTM is FDA approved to help people who have a hard time controlling their bowl movements. This is called fecal incontinence.The device is placed near a nerve root in the lower back. It works in a manner similar to a pacemaker by releasing electrical stimulation that triggers the S3 nerve root. When being placed, it is initially tested to make sure it will work using a temporary wire and then, if successful, the device is permanently implanted.
Primary Outcome
Bowel function will be assessed by using the MSK BFI. We have chosen the BFI because it is widely endorsed to assess the clinical problem that these patients have. The BFI is a 19 item instrument to which a patient responds using a 5-point Likert scale, ranging from Always to Never.
Interventions
- DEVICE Implantation of the InterStimTM
- BEHAVIORAL MSK BFI questionnaires
- BEHAVIORAL The Low Anterior Resection Score (LARS) questionnaires
- BEHAVIORAL The EuroQOL5D questionnaires
- BEHAVIORAL The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-06-10 |
| Est. Completion | 2016-12-19 |
| Phase | Phase 2 |
Why NCT02163187 stopped before completion
NCT02163187 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 5 interventions - of which Implantation of the InterStimTM is the first listed.
NCT02163187 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02163187 about?
NCT02163187 is a clinical study titled "Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation". The purpose of this study is to evaluate whether a medical device/implant (InterStimTM) will help patients to have more normal bowel movements. The InterStimTM device is a neuromodulating device. Neuromodulation is a way of changing the activity of the nervous system by using electrical stimulation....
What is the current status of trial NCT02163187?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2014-06-10. Estimated completion is 2016-12-19.
What interventions are being tested in trial NCT02163187?
The interventions under investigation include: Implantation of the InterStimTM (DEVICE), MSK BFI questionnaires (BEHAVIORAL), The Low Anterior Resection Score (LARS) questionnaires (BEHAVIORAL), The EuroQOL5D questionnaires (BEHAVIORAL), The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires (BEHAVIORAL).
Who is sponsoring clinical trial NCT02163187?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02163187's enrollment target sits among peer trials
4 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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