Trial to Visualize the Ureters With Nizaracianine Triflutate in Adults Undergoing Abdominopelvic Surgery

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

336

Participants

Timeline

Start Date

June 28, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

March 31, 2026

Conditions
Injury of Ureter During Surgery (Disorder)
Interventions
DRUG

Nizaracianine Triflutate

Participants will receive up to 3 intravenous bolus injections with a minimal interval between doses of 60 minutes (surgeon discretion). Dose will be 1.0 or 2.5 mg depending on trial phase.

DRUG

Placebo Comparator

In Phase 3A only, \~50 subjects will be randomly allocated to receive sugar placebo

Trial Locations (8)

90048

RECRUITING

Cedars Sinai Medical Center, Los Angeles

94063

RECRUITING

Board of Trustees of Leland Stanford Junior University, Redwood City

01655

RECRUITING

University of Massachusetts Chan Medical School, Worcester

9713 GZ Groningen

RECRUITING

University Medical Center Groningen, Groningen

9728 NT Groningen

RECRUITING

Martini Hospital, Groningen

2333 ZA Leiden

RECRUITING

Leiden University Medical Centre (LUMC), Leiden

3015 GD Rotterdam

RECRUITING

Erasmus Medical Centre, Rotterdam

8000 GK Zwolle

RECRUITING

Isala Zwolle, Zwolle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Leiden University Medical Center

OTHER

collaborator

Erasmus Medical Center

OTHER

collaborator

University of Massachusetts Chan Medical School, Worcester

UNKNOWN

collaborator

Stanford University

OTHER

collaborator

Cedars-Sinai Medical Center

OTHER

collaborator

University Medical Center Groningen

OTHER

collaborator

Martini Hospital Groningen

OTHER

collaborator

Isala

OTHER

lead

Curadel Surgical Innovations, Inc.

INDUSTRY