Status:
RECRUITING
Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
Lead Sponsor:
Jørgen Bjerggaard Jensen
Collaborating Sponsors:
University of Aarhus
Conditions:
Non-Muscle Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Aim: To investigate the feasibility and tolerability of the Olympus Soltive laser in treatment of large recurrent low-grade Ta tumours in an outpatient setting. Background: Non-muscle invasive bladde...
Detailed Description
The participant will be informed that they can at any time withdraw their consent without influence on their further treatment. Withdrawal can be both with regards to further recordings of data but al...
Eligibility Criteria
Inclusion
- At least one tumour with a diameter \> 1 cm
- Papillary/non-solid tumours
- Previous low-grade NMIBC
- Ability to understand the participant information orally and in writing, in Danish, Spanish, Czech or French respectively
- Signed consent form
Exclusion
- Tumour diameter \> 3cm
- Tumour in the prostatic urethra
- Previous CIS, high-grade disease or muscle invasive bladder cancer with no later low-grade recurrence
- Positive cytology within 3 months (testing not mandatory in patients with low-grade tumours)
- Pregnancy
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT05337397
Start Date
May 1 2022
End Date
April 1 2027
Last Update
August 8 2022
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200