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NCT07655284 · ClinicalTrials.gov registry record · Phase 3
STENT X: a Randomized Trial to Assess Stent-free Radical Cystectomy
A Phase 3 study, sponsored by Brigham and Women's Hospital.
- Not yet
- Registry status
- Phase 3
- Development phase
- 190
- Enrollment target
NCT07655284 is a Phase 3 study that has not yet begun recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 190 participants.
The verdict
NCT07655284, a Phase 3 study, has not yet begun recruiting, sponsored by Brigham and Women's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 190 participants
- Enrollment target
Study Summary
Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infections (UTIs), pyelonephritis, ureteroileal leakage and stenosis, and can occur with either ileal conduit or orthotopic neobladder diversions. Traditionally, ureteral stents are thought to support anastomotic healing and reduce the risk of anastomotic leakage and strictures; however, emerging evidence from retrospective studies suggests that stent use may paradoxically increase rates of postoperative morbidity. This randomized, multicenter and prospective study aims to compare 30-day postoperative complication rates between stented and non-stented urinary diversions in patients undergoing RC for MIBC, in both ileal conduit or neobladder with either robotic or open approaches.
Interventions
- DEVICE ureteral stents
- DEVICE no ureteral stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2029-08-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07655284
The ClinicalTrials.gov registry entry for NCT07655284 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ureteral stents is the first listed.
NCT07655284 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07655284 about?
NCT07655284 is a clinical study titled "STENT X: a Randomized Trial to Assess Stent-free Radical Cystectomy". Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infec...
What is the current status of trial NCT07655284?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2026-09-01. Estimated completion is 2029-08-31.
What interventions are being tested in trial NCT07655284?
The interventions under investigation include: ureteral stents (DEVICE), no ureteral stent (DEVICE).
Who is sponsoring clinical trial NCT07655284?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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