NCT07234968 Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
| NCT ID | NCT07234968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Thomas Jefferson University |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-12-23 |
| Primary Completion | 2028-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-12-23 with a primary completion date of 2028-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Subjects will be randomized into 2 groups (stent or no stent) prior to radical cystectomy with ileal conduit urinary diversion (RCIC). They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.
Eligibility Criteria
Inclusion Criteria: * Individuals must meet all the following inclusion criteria to be eligible to participate in the study: * Provide signed and dated informed consent form * Willing to comply with all study procedures and be available for the duration of the study * Male or female, age 18 to 85 * Diagnosed with bladder cancer, other pelvic malignancies necessitating a cystectomy (e.g.: colorectal, prostate, gynecologic) and have elected for a cystectomy with ileal conduit urinary diversion Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: * Current or history of pelvic radiation * Retroperitoneal fibrosis * Untreated urinary tract infection (UTI) within 30 days prior to RCIC * Pregnancy
Contact & Investigator
Mihir S Shah, MD
PRINCIPAL INVESTIGATOR
Thomas Jefferson University
Frequently Asked Questions
Who can join the NCT07234968 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07234968 currently recruiting?
Yes, NCT07234968 is actively recruiting participants. Contact the research team at Mihir.Shah@jefferson.edu for enrollment information.
Where is the NCT07234968 trial being conducted?
This trial is being conducted at Philadelphia, United States, Philadelphia, United States.
Who is sponsoring the NCT07234968 clinical trial?
NCT07234968 is sponsored by Thomas Jefferson University. The principal investigator is Mihir S Shah, MD at Thomas Jefferson University. The trial plans to enroll 70 participants.
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