Condition: Non-Muscle Invasive Bladder Cancer · Sponsor: Jørgen Bjerggaard Jensen
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 bladder cancer (NMIBC) is associated with a high yearly recurrence rate up to to 61%. Patients affected are therefore referred to long-term or even life-long follow-up, which burdens both patients and health care system. Recurrent tumours are most frequently treated with TURBT followed by adjuvant intravesical treatment. Repeat TURBT includes a risk of morbidity from the procedure itself and from general anaesthetics, which the procedure requires. Patients with NMIBC are generally elderly, multi-morbid, and as a result, they often show a poor tolerability of general anaesthetics. Thus, the need for non-surgical treatment modalities is imminent and continuous investigations are performed in the field including active surveillance, chemoresection and device-assisted intravesical chemotherapy. Laser ablation is a technique gaining attention in the treatment of NMIBC, based on the prospects of an outpatient treatment modality, which could prove TURBT and general anaesthesia unnecessary in select patients. Methods: The study will be conducted as a prospective feasibility study. Included patients will undergo outpatient laser ablation using the Olympus Soltive laser under local anaesthetics. Patients will be included from Aarhus University Hospital (Denmark), Fundació Puigvert (Spain), Mot…
This description comes directly from the study's public registry record.
Jørgen B Jensen, Professor MD · +4578452617 · bjerggaard@skejby.rm.dk
Vanaja Kumarasegaram, MD · 81732030 · vanajak87@gmail.com
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| Aarhus University Hospital | Aarhus, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05337397