Feasibility of Automatic, Laser-based Distance Control in Persons With Superficial Bladder Tumors
ConditionNMIBC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOptheras AS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
People with bladder tumor(s) detected during surveillance cystoscopy and booked for outpatient laser treatment of the tumor(s)
Disqualifiers
Macroscopic hematuria
Pregnant or breastfeeding women
Expected poor compliance
Dementia
Trial design
Design model
Single group
Treatments tested in this trial
ATLAS system
DeviceThis 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Intervention: ATLAS systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Distance sensing of bladder tumor tissue
ATLAS-010-110-L1A distance range measured on tumor tissue. The distance range is defined as the longest distance the system can detect in a 10 second period of continuous measurement. Range is a measure of both the reflection properties of the tissue and the quality of the detection by the sensor. If flat papillary tumor tissue is present in the bladder, the measurement will be performed on this tissue. The range measured on bladder tumor tissue in humans is compared to the range previously measured in pigs on normal bladder tissue during in-vivo experiments to test whether human bladder tumor tissue reflects the sensor's light well enough for the system to detect it from as far away as it could detect normal bladder tissue in pigs.
Time frame
At baseline visitSecondary outcomes
1
Distance sensing of normal bladder tissue
ATLAS-010-110-L1A distance range measured on normal bladder tissue. The range measured on normal bladder tissue in humans is compared to the range previously measured in pigs during in-vivo experiments.
Time frame
At baseline visitOther outcomes
1
Guide beam visibility
Structured feedback on the functionality of the guide beam is collected through a questionnaire answered by the physician after each procedure. The questionnaire collects feedback on the light intensity of the guide beam on different distances from the bladder wall. A video of the guide beam function is recorded by the cystoscope.
Time frame
At baseline visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov