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Feasibility of Automatic, Laser-based Distance Control in Persons With Superficial Bladder Tumors
Sponsor: Optheras AS
Summary
The goal of this clinical investigation is to test the sensing and guiding part of the ATLAS system in the human bladder of people with Ta low grade bladder tumors. The main questions it aims to answer are: Does the distance sensor of the ATLAS system work as well on human bladder tumor tissue as in normal pig bladder tissue? Does the distance sensor of the ATLAS system work as well on normal human bladder tissue as in normal pig bladder tissue? Participants will be asked to have their scheduled outpatient laser treatment of bladder tumor(s), detected during surveillance cystoscopy, expanded by approximately 5 minutes.
Official title: An In-vivo Feasibility Study of Laser-based Automatic Irradiance Control in Persons With Superficial Bladder Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-10-02
Completion Date
2027-03
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
ATLAS system
This version of the ATLAS system is aimed at evaluating a distance sensor and a guide beam. The version of the ATLAS system developed for this investigation does not contain a treatment laser.
Locations (1)
Herlev Hospital, Department of Urology
Herlev, Denmark