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NCT06101745 · ClinicalTrials.gov registry record · Phase 2
Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery
A Phase 2 study of Injury of Ureter During Surgery (Disorder), sponsored by Curadel Surgical Innovations.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 336
- Enrollment target
- 10
- Study locations
NCT06101745: Recruiting Phase 2 study of Injury of Ureter During Surgery (Disorder), sponsored by Curadel Surgical Innovations.
NCT06101745 is a Phase 2 study of Injury of Ureter During Surgery (Disorder) that is actively recruiting participants, run by Curadel Surgical Innovations. The registered enrollment target is 336 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (153% higher). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06101745, a Phase 2 study of Injury of Ureter During Surgery (Disorder), is actively recruiting participants, sponsored by Curadel Surgical Innovations.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 336 participants
- Enrollment target
- 10
- Study locations
Study Summary
The goal of this clinical trial is to determine if the drug Nizaracianine Triflutate can help surgeons see and avoid the ureters during abdominopelvic surgery. The ureters are thin-wall, collapsible tubes that connect the kidneys to the bladder. They are difficult to see during surgery and are sometimes damaged accidentally. The main questions to answer are: 1) is this drug safe for use in patients undergoing abdominopelvic surgery and 2) can the drug see the ureters while simultaneously providing information about how well they are working. The clinical trial has 3 parts. Surgery patients enrolled in the first part (Phase 2) will receive drug at different doses to determine the best dose. Patients enrolled in the second part (Phase 3A) will be randomly assigned to drug or placebo (sugar), at the best dose from Phase 2, so the two can be compared directly. Patients enrolled in the final part (Phase 3B) will all receive drug at the best dose from Phase 2.
Primary Outcome
The proportion of subjects for whom the surgeon is able to successfully identify the required length of the ureters (specified by the surgeon at each timepoint) with a peak signal-to-background ratio (SBR) ≥ 1.5 where SBR is signal-to-background ratio - verified by three independent blinded reviewers
Conditions Studied
Interventions
- DRUG Placebo Comparator
- DRUG Nizaracianine Triflutate
Study Locations (10)
Other
- University Medical Center Groningen - Groningen
- Martini Hospital - Groningen
- Leiden University Medical Centre (LUMC) - Leiden
- Erasmus Medical Centre - Rotterdam
- Isala Zwolle - Zwolle
California
- Cedars Sinai Medical Center - Los Angeles
- Board of Trustees of Leland Stanford Junior University - Redwood City
Florida
- AdventHealth Orlando - Orlando
- AdventHealth Tampa - Tampa
Massachusetts
- University of Massachusetts Chan Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2024-06-28 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
What NCT06101745 shows while recruiting
NCT06101745 is an interventional study that assigns participants to a tested intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (153% higher).
The record links to 1 condition, with Injury of Ureter During Surgery (Disorder) appearing as the primary indexed condition, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT06101745 lists 10 locations in 4 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT06101745 about?
NCT06101745 is a clinical study titled "Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery". The goal of this clinical trial is to determine if the drug Nizaracianine Triflutate can help surgeons see and avoid the ureters during abdominopelvic surgery. The ureters are thin-wall, collapsible tubes that connect the kidneys to the bladder. They are difficult to see during surgery and are somet...
What is the current status of trial NCT06101745?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 336 participants. The study started on 2024-06-28. Estimated completion is 2026-08.
What conditions does trial NCT06101745 study?
This clinical trial studies the following conditions: Injury of Ureter During Surgery (Disorder).
What interventions are being tested in trial NCT06101745?
The interventions under investigation include: Placebo Comparator (DRUG), Nizaracianine Triflutate (DRUG).
Who is sponsoring clinical trial NCT06101745?
This trial is sponsored by Curadel Surgical Innovations, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06101745 being conducted?
This trial has 10 study locations across California, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06101745's enrollment target sits among peer trials
336 141st of 2000 higher than 1,859 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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