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NCT07080008
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
Phase 1 trial testing Lumitrace in Ureter Injury in 10 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | MediBeacon |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 10 |
| Start date | 30 January 2026 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lumitrace — full drug profile →
- KARL STORZ POWER LED BLUE System
Conditions studied
- Ureter Injury — all drugs for Ureter Injury →
Sponsor
MediBeacon — full company profile →
Who can join
18 and older, any sex, with Ureter Injury. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Intra-participant difference in laparoscopic view of ureter conspicuity for white light (WL) versus fluorescence (BLUE)
Time frame: Day of surgery
Imaging will be acquired within 30 minutes post Lumitrace administration. Images from one or both ureters may be evaluated for anatomical visualization. Following the initial endoscopic surgical incision, the surgeon will record the image assessments based on the Likert Scales as follows. White light visibility will be measured using a 4-point scale where 0 represents not visible and 3 represents
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07080008
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ureter Injury
Currently open trials in the same condition.
- NCT06987760 — Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones · NA · recruiting
- NCT06085183 — Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment · Phase 4 · recruiting
- NCT06054880 — Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency · Phase 4 · recruiting
Other MediBeacon trials
Trials by the same sponsor.
- NCT05777174 — Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable · Phase 3 · completed
- NCT05425719 — Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation · Phase 3 · completed
- NCT03962998 — Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability · EARLY_PHASE1 · completed
- NCT03810833 — Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System · NA · completed
- NCT02772276 — Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Nor · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07080008 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MediBeacon
- Last refreshed: 31 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07080008.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing