LUMINA I
An In-vivo Feasibility Study of Laser-based Automatic Irradiance Control in Persons With Superficial Bladder Tumors
Sponsor study identifier
interventional
25
1 country
1
Study Start
October 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 18, 2026
Actual (reported)October 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 6, 2026
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
At baseline visit
Distance sensing of normal bladder tissue
At baseline visit
Guide beam visibility
At baseline visit
The participants are patients booked for outpatient laser treatment of superficial bladder tumors. The planned laser treatment will be performed through a flexible cystoscope. Normal treatment procedure is initiated with a cystoscopy to identify tumors. The investigation intervention will be performed after the cystoscopy by inserting a catheter including the ATLAS laser fiber. Measurements on bladder tumors and normal tissue will be performed. The normal treatment procedure will take place subsequent to the investigation procedure. The investigation procedure will prolong the planned laser treatment with approximately 5 minutes. A follow-up telephone call will be conducted after 7-10 days to interview the participants regarding adverse events. The number of participants to be enrolled is set at 25 to account for dropouts due to, e.g., a urinary tract infection on the day of the procedure. This size was chosen to ensure that 20 participants complete according to protocol.
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.
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Herlev Hospital, Department of Urology
Herlev, 2730, Denmark
First Submitted
September 18, 2026
First Posted
October 6, 2026
Study Start
October 2, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2027
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 6, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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