Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
Recruiting · NCT07234968 · Interventional (participants receive a specific treatment) · Lead sponsor: Thomas Jefferson University
View the official record on ClinicalTrials.gov →Interventions studied
Indocyanine Green with Fluorescence ImagingNo Ureteral StentUreteral Stent Placement
What this trial is about
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.
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Thomas Jefferson University Hospital - Philadelphia, Pennsylvania, United States
- Jefferson Einstein Philadelphia Hospital - Philadelphia, Pennsylvania, United States