Actively Recruiting
A Single Center, Open Label Pilot Study to Assess the Feasibility and Safety of Lumitrace Injection for Intraoperative Ureter Visualization Comparing White Light and Fluorescence in Minimally Invasive Abdominopelvic Surgeries
Led by MediBeacon · Updated on 2026-04-01
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Lumitrace and the KARL STORZ POWER LED BLUE System for visualizing the ureters during laparoscopic abdominopelvic surgery. The study aims to assess whether these tools can effectively highlight the ureters and to check the safety and tolerability of a single intravenous dose of Lumitrace in participants undergoing this type of surgery. Participants will receive a single 130 mg dose of Lumitrace through an intravenous injection. Within 30 minutes of the injection, the KARL STORZ POWER LED BLUE System will capture images of the ureters using white light and fluorescence. Surgeons will then rate the visibility of the ureters under each lighting mode based on qualitative scales. Those taking part will have a screening visit within 28 days before Lumitrace administration. After the surgery, a safety follow-up visit will happen within about two weeks. Researchers will assess the difference in ureter visibility between white light and fluorescence during surgery, monitor safety, and collect information on the tolerability of Lumitrace.
CONDITIONS
Brief Title
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 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 willing to abstain or use adequate contraception from dosing day to at least 30 days post-dose
- Women of child-bearing potential must have a negative serum pregnancy test on day of surgery and agree to use acceptable contraception consistently from consent through 30 days after Lumitrace administration
- Men will not donate sperm during the study and for 30 days following Lumitrace dose
- Participants capable of providing informed consent and complying with study requirements
- Participants 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...
- Any serious or uncontrolled physical or psychiatric condition that limits ability to complete study or increases risk
- Anticipated need for ureteral stenting during surgery
- Active urinary tract infection requiring antibiotics
- Moderate to severe cardiac disease limiting daily function (NYHA Class III-IV) or other medical conditions impacting safety or compliance
- Clinically relevant laboratory abnormalities contraindicating surgery
- Body weight less than 30 kilograms
- History of severe allergic reactions or anaphylactoid reactions to drugs, Lumitrace, or related products
- Received investigational therapy within 30 days or 5 half-lives prior to 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive a single intravenous dose of Lumitrace during minimally invasive abdominopelvic surgery. Within 30 minutes of injection, ureter visualization is captured using specialized imaging systems under white light and fluorescence.
1 surgical visit (in-person)
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
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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