NCT07080008

Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: MediBeacon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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

• Ureter Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-07-23
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study