NCT02163187 is a Phase 2, PHASE3 clinical trial of Implantation of the InterStimTM in Rectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center.

Who is sponsoring NCT02163187?

NCT02163187 is sponsored by Memorial Sloan Kettering Cancer Center.

What drugs are being tested in NCT02163187?

Interventions in NCT02163187: Implantation of the InterStimTM, MSK BFI questionnaires, The Low Anterior Resection Score (LARS) questionnaires, The EuroQOL5D questionnaires, The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires.

What condition does NCT02163187 study?

NCT02163187 studies Rectal Cancer, for Bowel Dysfunction Following Surgery for Rectal Cancers.

Is NCT02163187 still recruiting?

NCT02163187 is currently terminated. Last updated 5 February 2018.

Are results published for NCT02163187?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-02-05 · How we verify

NCT02163187

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Sacral Neuromodulation (SNM) With InterStimTM for Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation

Terminated Phase 2, PHASE3 Results posted Last updated 5 February 2018

What this trial tests

Phase 2, PHASE3 trial testing Implantation of the InterStimTM in Rectal Cancer in 4 participants. Terminated before completion.

Timeline

10 June 2014

Primary endpoint
19 December 2016

19 December 2016

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	4
Start date	10 June 2014
Primary completion	19 December 2016
Estimated completion	19 December 2016
Sites	2 locations across United States

Drugs / interventions tested

Implantation of the InterStimTM
MSK BFI questionnaires
The Low Anterior Resection Score (LARS) questionnaires
The EuroQOL5D questionnaires
The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires

Conditions studied

Rectal Cancer — all drugs for Rectal Cancer →
for Bowel Dysfunction Following Surgery for Rectal Cancers — all drugs for for Bowel Dysfunction Following Surgery for Rectal Cancers →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, any sex, with Rectal Cancer or for Bowel Dysfunction Following Surgery for Rectal Cancers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Rectal Cancer

Currently open trials in the same condition.

NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07537998 — Antegrade Intestinal Fluid Reinfusion for Prevention of Low Anterior Resection Syndrome After Low Anterior Resection: a · Phase 2, PHASE3 · recruiting
NCT07501845 — Registry Maastro Applicator · recruiting
NCT07369531 — The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-pres · NA · recruiting
NCT07505472 — Efficacy and Safety Comparison of Short-course Radiotherapy Followed by CapeOX Chemotherapy Plus Toripalimab With or Wit · Phase 2, PHASE3 · recruiting

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02163187 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
Last refreshed: 5 February 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02163187.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing