Status:
COMPLETED
An International Randomized Study to Compare SPIES Versus WLI
Lead Sponsor:
Clinical Research Office of the Endourological Society
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a multicenter randomized controlled trial in which the efficacy between SPIES assisted and WLI assisted TURB are compared. Subjects in the experimental arm (Arm A) will undergo SPIES ass...
Detailed Description
This study is a multicenter randomized controlled trial in which the recurrence rates of cancer between SPIES assisted and WLI assisted TURB are compared. Randomization is stratified by tumor multipli...
Eligibility Criteria
Inclusion
- Has signed informed consent
- Is scheduled for treatment of a primary or recurrent NMIBC
- Is aged 18 years or older
- Has or has had no tumors in the upper urinary tract
- Has had no previous irradiation of the pelvis
Exclusion
- Gross haematuria at the time of TURB (i.e. heavy bladder bleeding resulting in marked amounts of blood in the urine which may interfere with cystoscopy)
- Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
- Pregnancy or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and are suggested to use the contraceptive pill or an intrauterine device (IUD) during the treatments and for at least one months thereafter)
- Conditions associated with a risk of poor protocol compliance
- Has had instillation therapy in the six months prior to the screening visit
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT02252549
Start Date
April 1 2015
End Date
July 1 2021
Last Update
July 28 2021
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