NMIBCLUMINA INCT07860398
Feasibility of Automatic, Laser-based Distance Control in Persons With Superficial Bladder Tumors
A study testing ATLAS system in people with NMIBC, run by Optheras AS at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NMIBC
- What is being tested?
- ATLAS system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Oct 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with bladder tumor(s) detected during surveillance cystoscopy and booked for outpatient laser treatment of the tumor(s)
Who cannot join
- Macroscopic hematuria
- Pregnant or breastfeeding women
- Expected poor compliance
- Dementia
- Persons under 18 years of age
- Persons who do not read or understand Danish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev Hospital, Department of Urology
Herlev, 2730
Pedersen, +45 38 68 01 48, heh-urologisk.afdeling.h@regionh.dk
About this study
Official title: An In-vivo Feasibility Study of Laser-based Automatic Irradiance Control in Persons With Superficial Bladder Tumors
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.
Read the detailed description
The primary purpose is designated as 'Other' because this is a traditional feasibility investigation evaluating initial clinical safety and performance in 25 subjects to support a future pivotal investigation. The investigation is conducted in EU (Denmark).
- Conditions
- NMIBC
- Being tested
- ATLAS system
- Keywords
- LUMINA I, ATLAS system, distance sensor
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATLAS systemDevice
Also called ATLAS-010-110-L1A
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: ATLAS system | Experimental | 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. Receives: Device: ATLAS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline visit
Secondary 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.
Measured: At baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start2 Oct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NMIBCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optheras AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860398
- Sponsor's protocol ID
- CIV-26-06-058854
- Acronym
- LUMINA I
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-vivo Feasibility Study of Laser-based Automatic Irradiance Control in Persons With Superficial Bladder Tumors
- ClinicalTrials.gov ID
- NCT07860398
- Acronym / sponsor ID
- LUMINA I / CIV-26-06-058854
- Conditions
- NMIBC
- Keywords
- LUMINA I, ATLAS system, distance sensor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Optheras ASIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary purpose is designated as 'Other' because this is a traditional feasibility investigation evaluating initial clinical safety and performance in 25 subjects to support a future pivotal investigation. The investigation is conducted in EU (Denmark).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: ATLAS system | Experimental | Device: ATLAS systemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People with bladder tumor(s) detected during surveillance cystoscopy and booked for outpatient laser treatment of the tumor(s)
Key exclusion criteria (6 listed)
- Macroscopic hematuria
- Pregnant or breastfeeding women
- Expected poor compliance
- Dementia
- Persons under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATLAS systemAlso: ATLAS-010-110-L1AThis 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. | Device | Intervention: ATLAS system |
Primary outcome
Distance sensing of bladder tumor tissue
Time frame: At baseline visit
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.
1 secondary outcome
Distance sensing of normal bladder tissue
Time frame: At baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for NMIBC
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
Active, not recruitingPhase 2
Intravesical Gem/Doce in Patients With NMIBC
Urinary Bladder Cancer
Active, not recruitingPhase 3
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
High-risk Non-muscle Invasive Bladder Cancer
RecruitingObservational study
Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
Bladder Cancer, Recurrent Bladder Cancer
Active, not recruitingPhase 3
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
Non-muscle Invasive Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATLAS system in people with NMIBC, run by Optheras AS at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Head of Clinical Affairs (+45 93 56 40 00, contact@optheras.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance sensing of bladder tumor tissue (time frame: At baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.