Actively Recruiting
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
Led by MediBeacon · Updated on 2026-04-01
10
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Female participants must not be pregnant and either not of child-bearing potential or willing to use effective contraception during the trial
- Male participants must agree to abstinence or use contraception from dosing day to 30 days after
- Women of child-bearing potential must have a negative pregnancy test on surgery day and use approved contraception consistently from consent through 30 days post-dose
- Male participants must not donate sperm during the study and for 30 days after Lumitrace dose
- Ability to provide informed consent and comply with study requirements
- Scheduled for minimally invasive laparoscopic abdominopelvic surgery requiring ureter identification
- Estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73m2 or higher
You will not qualify if you...
- Serious or uncontrolled physical or psychiatric conditions limiting study completion or increasing risk
- Expected need for ureteral stenting during surgery
- Active urinary tract infection requiring antibiotic treatment
- Moderate to severe cardiac disease limiting daily activities (NYHA Class III or IV) or other safety-impacting medical conditions
- Clinically relevant lab abnormalities contraindicating surgery per investigator
- Body weight less than 30 kilograms
- History of severe allergic or anaphylactoid reactions to any allergen including Lumitrace
- Receipt of investigational therapy within 30 days or 5 half-lives before screening
- Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73m2
- Positive serum pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Missouri, Kansas, City, School of Medicine; Division of Urogynecology and Reconstructive Pelvic Surgery,
Kansas City, Missouri, United States, 64108
Actively Recruiting
Research Team
R
Richard B Doshow, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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