Outpatient laser treatment for recurrent bladder cancer
Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
This study is testing if a new outpatient laser treatment can safely help people with recurring low-grade bladder cancer without the need for general anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 145 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT05337397 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and tolerability of using the Olympus Soltive laser to treat large recurrent low-grade Ta tumors in an outpatient setting. Non-muscle invasive bladder cancer (NMIBC) has a high recurrence rate, leading to burdensome long-term follow-ups for patients. The study aims to provide a less invasive alternative to traditional treatments, which often require general anesthesia and can pose risks, especially for elderly and multi-morbid patients. Participants will be informed about their rights and the study's procedures, ensuring ethical standards are maintained throughout.
Who should consider this trial
Good fit: Ideal candidates include patients with at least one low-grade NMIBC tumor larger than 1 cm but smaller than 3 cm.
Not a fit: Patients with high-grade disease, muscle invasive bladder cancer, or those with tumors larger than 3 cm will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive surgeries and improve the quality of life for patients with recurrent bladder cancer.
How similar studies have performed: While this approach is innovative, similar studies exploring outpatient laser treatments for bladder cancer have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Aarhus
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Jørgen B Jensen, Professor, MD — Skejby University Hospital: Aarhus Universitetshospital
- Study coordinator: Jørgen B Jensen, Professor MD
- Email: bjerggaard@skejby.rm.dk
- Phone: +4578452617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.