Status:
WITHDRAWN
Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Non-muscle Invasive Bladder Cancer (NMIBC)
Bladder Tumor (TURBT)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this pilot study is to determine if washing out the bladder with large volumes of saline after surgical removal of bladder tumors helps to decrease the number of loose cells floating wi...
Detailed Description
Bladder tumor recurrence after resection of non-muscle invasive bladder cancer (NMIBC) occurs in 50-70% of patients despite the use of adjuvant anticancer therapy after surgery. This is a single-arm, ...
Eligibility Criteria
Inclusion
- Patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging study
- Primary bladder tumor occurrence
Exclusion
- Patients with unresectable bladder tumors, as determined at the time of diagnosis or TURBT , or imaging concerning of T2 or higher disease
- Patients with bladder perforation at the time of TURBT, which is a contraindication to CBI
- Patients from vulnerable populations, including but not limited to impaired subjects, pregnant women, prisoners, family members of the study team
- Any previous history of bladder tumor resection or intravesical chemotherapy/immunotherapy
- History of previous pelvic radiation
- Bladder tumor volume \> 5 cm, involvement of prostatic urethra, or any evidence of hydronephrosis on imaging
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03839472
Start Date
September 1 2019
End Date
December 1 2022
Last Update
May 11 2022
Active Locations (1)
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1
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106