NCT07080008 · MediBeacon
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Lumitrace
Administered as a bolus intravenous injection over 30 - 60 seconds
DEVICE
KARL STORZ POWER LED BLUE System
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.
Primary outcome measures
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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)
- 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
Where
- Kansas City, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations