Outpatient laser treatment for recurrent bladder cancer
Official title: Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
Run by Aarhus University Hospital · NCT05337397 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 145 (estimated) |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aarhus) |
| Status | Recruiting |
| Started | May 1, 2022 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2027 |
| Registry record updated | August 8, 2022 |
| Trial ID | NCT05337397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with at least one low-grade NMIBC tumor larger than 1 cm but smaller than 3 cm.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies exploring outpatient laser treatments for bladder cancer have shown promising results.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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NMIBC sample collection to test cancer monitoring biomarkers
This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.
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Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC
This study tests whether adding docetaxel after gemcitabine is better or worse than adding mitomycin C after gemcitabine for people with BCG-unresponsive high-grade non-muscle-invasive bladder cancer.
-
Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?
This study tests whether patients who have become tumor-free after a systemic immunotherapy-based bladder-sparing treatment can safely stop therapy and instead be watched closely.
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Comparing CT and MRI with VI-RADS for Bladder Cancer Staging
This study tests how well CT and MRI with VI-RADS can correctly stage bladder cancer before surgery in adults.
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How bladder microbes and immune signals affect lower urinary tract health
This project will test whether differences in bladder microbes and immune signals are linked to urinary tract health in adults with and without various urinary conditions.
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Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer
This treatment will test cretostimogene plus n‑dodecyl‑β‑D‑maltoside in adults whose high‑grade non‑muscle‑invasive bladder cancer did not respond to BCG (carcinoma in situ with or without Ta/T1 tumors).
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.