Feasibility of automatic, laser-based distance control in people with superficial bladder tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study evaluates the ATLAS system’s distance sensor in human bladder tissue during outpatient laser treatment of Ta low-grade bladder tumors. It compares sensor performance in human tumors, normal human bladder tissue, and pig bladder tissue to gauge transferability of measurements. Twenty-five subjects in Denmark will have an approximately five-minute extension added to their planned procedure to assess safety and initial performance in a real clinical setting. The primary aim is to support a future pivotal study by examining feasibility and safety rather than proving clinical effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* People with bladder tumor(s) detected during surveillance cystoscopy and booked for outpatient laser treatment of the tumor(s)

Exclusion Criteria:

* Macroscopic hematuria
* Pregnant or breastfeeding women
* Expected poor compliance
* Dementia
* Persons under 18 years of age
* Persons who do not read or understand Danish

Where it's running

• Herlev Hospital, Department of Urology
  Herlev, Denmark Recruiting

Study contacts

• Study coordinator: Head of Clinical Affairs
• Email: contact@optheras.com
• Phone: +45 93 56 40 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.