Actively Recruiting
Pilot Study Assessing Safety and Use of Lumitrace for Ureter Visualization During Minimally Invasive Abdominopelvic Surgery with KARL STORZ POWER LED BLUE System
Led by MediBeacon · Updated on 2026-04-01
10
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
R
Richard B Doshow, PhD
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