Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02163187
The ClinicalTrials.gov registry entry for NCT02163187 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Implantation of the InterStimTM is the first listed.
NCT02163187 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.