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Feasibility of Automatic, Laser-based Distance Control in Persons With Superficial Bladder Tumors

Sponsor: Optheras AS • ClinicalTrials.gov ID: NCT07860398

Registry updated: 2026-10-06

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Description

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.

Interventions

ATLAS system (Device)
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.

Eligibility criteria

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

Conditions

NMIBC

Locations

Herlev Hospital, Department of Urology — Herlev, Denmark

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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