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NCT03106038

Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery

Completed Phase 1, PHASE2 Last updated 26 November 2019
What this trial tests

Phase 1, PHASE2 trial testing Nerindocianine for Injection in Intraoperative Ureter Injury in 41 participants. Completed in 19 November 2018.

Timeline
26 April 2017
Primary endpoint
19 November 2018
19 November 2018

Quick facts

Lead sponsorLi-Cor, Inc.
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Designsequential
Maskingnone
Primary purposediagnostic
Enrollment41
Start date26 April 2017
Primary completion19 November 2018
Estimated completion19 November 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Li-Cor, Inc. — full company profile →

Who can join

19 and older, female only, with Intraoperative Ureter Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Fluorescence Image-Guided Surgery - a Perspective on Contrast Agent Development.
    Barth CW, Gibbs SL. · · 2020 · cited 79× · PMID 32255887 · DOI 10.1117/12.2545292
  2. Currently available and experimental dyes for intraoperative near-infrared fluorescence imaging of the ureters: a systematic review.
    Slooter MD, Janssen A, Bemelman WA, Tanis PJ, et al · · 2019 · cited 35× · PMID 31030340 · DOI 10.1007/s10151-019-01973-4
  3. Intraoperative ureter identification with a novel fluorescent catheter.
    Barberio M, Al-Taher M, Felli E, Ashoka AH, et al · · 2021 · cited 14× · PMID 33627768 · DOI 10.1038/s41598-021-84121-z

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