Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
MediBeacon
Study ID
NCT07080008
Phase
PHASE1
Status
Recruiting
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Conditions

  • Ureter Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lumitrace — DRUG
    Administered as a bolus intravenous injection over 30 - 60 seconds
  • KARL STORZ POWER LED BLUE System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 30, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: 130 mg Lumitrace
    Participants 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.

Primary Outcome Measure

Intra-participant difference in laparoscopic view of ureter conspicuity for white light (WL) versus fluorescence (BLUE) [ Time Frame: Day of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Missouri, Kansas, City, School of Medicine; Division of Urogynecology and Reconstructive Pelvic Surgery,Kansas CityMissouri64108-

Find similar trials in Kansas City, MO

By research site
University of Missouri, Kansas, City, School of Medicine; Division of Urogynecology and Reconstructive Pelvic Surgery· Kansas City, MO

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