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NCT07080008 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
A Phase 1 study of Ureter Injury, sponsored by MediBeacon.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT07080008 is a Phase 1 study of Ureter Injury that is actively recruiting participants, run by MediBeacon. The registered enrollment target is 10 participants, below the 114-participant average among 5 other Ureter Injury trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07080008, a Phase 1 study of Ureter Injury, is actively recruiting participants, sponsored by MediBeacon.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DRUG Lumitrace
- DEVICE KARL STORZ POWER LED BLUE System
Study Locations (1)
Missouri
- University of Missouri, Kansas, City, School of Medicine; Division of Urogynecology and Reconstructive Pelvic Surgery, - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-01-30 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07080008
The ClinicalTrials.gov registry entry for NCT07080008 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 114-participant average among 5 other Ureter Injury trials with a reported enrollment target (91% lower). The listed sponsor is MediBeacon, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ureter Injury appearing as the primary indexed condition, and to 2 interventions - of which Lumitrace is the first listed.
NCT07080008 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT07080008 about?
NCT07080008 is a clinical study titled "Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries". 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 clinic...
What is the current status of trial NCT07080008?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2026-01-30. Estimated completion is 2026-09.
What conditions does trial NCT07080008 study?
This clinical trial studies the following conditions: Ureter Injury.
What interventions are being tested in trial NCT07080008?
The interventions under investigation include: Lumitrace (DRUG), KARL STORZ POWER LED BLUE System (DEVICE).
Who is sponsoring clinical trial NCT07080008?
This trial is sponsored by MediBeacon, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07080008 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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