Last updated: June 12, 2023
Sponsor: Jørgen Bjerggaard Jensen
Overall Status: Active - Recruiting
Phase
N/A
Condition
Bladder Cancer
Urothelial Cancer
Treatment
Conventional TURB
En Bloc resection
Clinical Study ID
NCT05223491
En Bloc
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Demographics: all BMI, smokers and non-smokers
- Primary, papillary, non-solid bladder tumour visualised by flexible cystoscopy
- Tumour diameter measured on CT-scan ≥2cm ≤6cm at largest diameter
- Ability to fully comprehend the information provided and comply with protocol
- Signed consent form
- Patients with multiple tumours can be included if it seems feasible to resect them inone procedure
Exclusion
Exclusion Criteria:
- Clinically suspected muscle invasive bladder cancer (invasion in to bladder muscle orextravesical extension visible on CT or solid tumour without papillary elements seenat cystoscopy)
- Tumour located in a bladder diverticulum
- Investigating physician concludes that en bloc resection is not technically possible
- Pregnancy
Study Design
Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Conventional TURB
Phase:
Study Start date:
March 17, 2022
Estimated Completion Date:
December 31, 2026
Connect with a study center
Department of Urology, Aalborg University Hospital
Aalborg, 9100
DenmarkActive - Recruiting
Department of Urology, Aarhus University Hospital
Aarhus, 8200
DenmarkActive - Recruiting
Department of Urology, Herlev Hospital
Herlev,
DenmarkActive - Recruiting
Department of Urology, Regional Hospital Gødstrup
Holstebro, 7500
DenmarkActive - Recruiting
Department of Urology, Odense University Hospital
Odense, 5000
DenmarkActive - Recruiting
Department of Urology, Zealand University Hospital
Roskilde, 4000
DenmarkActive - Recruiting
Urological Center, Paula Stradina Clinical University Hospital
Riga, LV-1002
LatviaActive - Recruiting
Department of Urology, Vestfold Hospital
Tønsberg, 3103
NorwayActive - Recruiting
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