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Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries

NCT07080008 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • MediBeacon

    lead INDUSTRY

Principal Investigators

  • Richard B Dorshow, PhD · MediBeacon, Inc.

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07080008 on ClinicalTrials.gov