Ureter InjuryPhase 1NCT07080008
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
A Phase 1 study testing Lumitrace and KARL STORZ POWER LED BLUE System in people with Ureter Injury, run by MediBeacon at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if Lumitrace and the KARL STORZ POWER LED BLUE System can be used for anatomic visualization of the ureters in participants undergoing laparoscopic abdominopelvic surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ureter Injury
- What is being tested?
- Lumitrace and KARL STORZ POWER LED BLUE System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to Dec 2026
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years - male or female
- Eligible female non-pregnant subjects who are either not of child-bearing potential or willing to use adequate contraception during the trial
- Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 30 days post-dose administration
- For women of child-bearing potential, the subject should have a negative serum pregnancy test on day of surgery, and agrees to one of the following acceptable contraceptive methods used consistently and correctly from the time of consent through 30 days after Lumitrace administration; i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system, or male partner sterilization
- Men will not donate sperm during the study and for 30 days following the last dose of Lumitrace
- Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
- Participant is scheduled to undergo minimally invasive laparoscopic abdominopelvic surgery that may require ureter(s) identification
- eGFR≥60 mL/min/1.73m2
Who cannot join
- Participant has any serious or uncontrolled physical or psychiatric condition that in the opinion of the investigator would limit the their ability to complete study requirements or may put the subject at increased risk, or compromise the interpretability of study results, which makes the participant unsuitable for study participation
- Participant is anticipated to require ureteral stenting during surgery
- Participant has an active urinary tract infection requiring antibiotic therapy
- Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions that would impact safety or study compliance
- Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the PI
- Participant with body weight < 30 kilogram (kg)
Show all 10Show fewer
- History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, Lumitrace or other related products (intolerance to a drug is not considered a drug allergy)
- Participant has received any investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening
- eGFR <60 mL/min/1.73m2
- Participants with positive serum pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri, Kansas, City, School of Medicine; Division of Urogynecology and Reconstructive Pelvic Surgery,
Kansas City, Missouri, 64108
About this study
Official title: A Single Center, Open Label Pilot Study to Assess the Feasibility and Safety of Lumitrace Injection for Intraoperative Ureter Visualization Comparing White Light (WL) Fluorescence (BLUE) in Participants Undergoing Minimally Invasive Abdominopelvic Surgeries
The goal of this clinical trial is to learn if Lumitrace and the KARL STORZ POWER LED BLUE System can be used for anatomic visualization of the ureters in participants undergoing laparoscopic abdominopelvic surgery.
The main questions it aims to answer are:
Read more
- To evaluate the feasibility and clinical utility of Lumitrace to provide ureter visualization when used in tandem with the KARL STORZ POWER LED BLUE System during laparoscopic abdominopelvic surgery
- To evaluate the safety and tolerability of a single intravenous dose of Lumitrace in participants undergoing laparoscopic abdominopelvic surgery
Participants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace.
Up to 10 participants will be enrolled and will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales.
A safety follow-up visit will occur within 14 ±7 days of Lumitrace administration.
- Conditions
- Ureter Injury
- Being tested
- Lumitrace, KARL STORZ POWER LED BLUE System
- Keywords
- Relmapirazin, Lumitrace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumitraceDrug
Also called Relmapirazin, MB-102
Administered as a bolus intravenous injection over 30 - 60 seconds
KARL STORZ POWER LED BLUE SystemDevice
Imaging will be acquired within 30 minutes post Lumitrace administration. Following the initial endoscopic surgical incision, the surgeon will record the image assessments based on Likert Scales.
| Study group | Role | What they receive |
|---|---|---|
| 130 mg Lumitrace | Experimental | Participants will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales. Receives: Drug: Lumitrace; Device: KARL STORZ POWER LED BLUE System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-participant difference in laparoscopic view of ureter conspicuity for white light (WL) versus fluorescence (BLUE)
Imaging will be acquired within 30 minutes post Lumitrace administration. Images from one or both ureters may be evaluated for anatomical visualization. Following the initial endoscopic surgical incision, the surgeon will record the image assessments based on the Likert Scales as follows.
White light visibility will be measured using a 4-point scale where 0 represents not visible and 3 represents excellent visibility. For images collected using the BLUE setting, intensity will be graded based on the following: (0 = none; 1 = mild; 2 = moderate; and 3 = strong).
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start30 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter InjuryStudies 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 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediBeacon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard B Dorshow, PhD, Study director, MediBeacon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080008
- Sponsor's protocol ID
- 400-100
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label Pilot Study to Assess the Feasibility and Safety of Lumitrace Injection for Intraoperative Ureter Visualization Comparing White Light (WL) Fluorescence (BLUE) in Participants Undergoing Minimally Invasive Abdominopelvic Surgeries
- ClinicalTrials.gov ID
- NCT07080008
- Acronym / sponsor ID
- 400-100
- Conditions
- Ureter Injury
- Keywords
- Relmapirazin, Lumitrace
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- MediBeaconIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jul 2025 (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 trial is to learn if Lumitrace and the KARL STORZ POWER LED BLUE System can be used for anatomic visualization of the ureters in participants undergoing laparoscopic abdominopelvic surgery.
The main questions it aims to answer are:
- To evaluate the feasibility and clinical utility of Lumitrace to provide ureter visualization when used in tandem with the KARL STORZ POWER LED BLUE System during laparoscopic abdominopelvic surgery
- To evaluate the safety and tolerability of a single intravenous dose of Lumitrace in participants undergoing laparoscopic abdominopelvic surgery
Participants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace.
Up to 10 participants will be enrolled and will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales.
A safety follow-up visit will occur within 14 ±7 days of Lumitrace administration.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 130 mg Lumitrace | Experimental | Drug: Lumitrace, Device: KARL STORZ POWER LED BLUE SystemParticipants will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years - male or female
- Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
- Participant is scheduled to undergo minimally invasive laparoscopic abdominopelvic surgery that may require ureter(s) identification
- eGFR≥60 mL/min/1.73m2
Key exclusion criteria (10 listed)
- Participant has any serious or uncontrolled physical or psychiatric condition that in the opinion of the investigator would limit the their ability to complete study requirements or may put the subject at increased risk, or compromise the interpretability of study results, which makes the participant unsuitable for study participation
- Participant is anticipated to require ureteral stenting during surgery
- Participant has an active urinary tract infection requiring antibiotic therapy
- Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions that would impact safety or study compliance
- Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the PI
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 |
|---|---|---|
| LumitraceAlso: Relmapirazin, MB-102Administered as a bolus intravenous injection over 30 - 60 seconds | Drug | 130 mg Lumitrace |
| KARL STORZ POWER LED BLUE SystemImaging will be acquired within 30 minutes post Lumitrace administration. Following the initial endoscopic surgical incision, the surgeon will record the image assessments based on Likert Scales. | Device | 130 mg Lumitrace |
Primary outcome
Intra-participant difference in laparoscopic view of ureter conspicuity for white light (WL) versus fluorescence (BLUE)
Time frame: Day of surgery
Imaging will be acquired within 30 minutes post Lumitrace administration. Images from one or both ureters may be evaluated for anatomical visualization. Following the initial endoscopic surgical incision, the surgeon will record the image assessments based on the Likert Scales as follows. White light visibility will be measured using a 4-point scale where 0 represents not visible and 3 represents excellent visibility. For images collected using the BLUE setting, intensity will be graded based on the following: (0 = none; 1 = mild; 2 = moderate; and 3 = strong).
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 13 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Richard B Dorshow, PhD study director
MediBeacon, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lumitrace and KARL STORZ POWER LED BLUE System in people with Ureter Injury, run by MediBeacon at 1 site in United States.
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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-participant difference in laparoscopic view of ureter conspicuity for white light (WL) versus fluorescence (BLUE) (time frame: Day of surgery). 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 13 Aug 2026.