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NCT03387410

Ureter Identification With IRDye 800BK

Completed Phase 1, PHASE2 Last updated 19 November 2018
What this trial tests

Phase 1, PHASE2 trial testing Intravenous IRDye 800BK in Ureter Injury in 40 participants. Completed in 16 November 2018.

Timeline
6 April 2018
Primary endpoint
1 November 2018
16 November 2018

Quick facts

Lead sponsorOxford University Hospitals NHS Trust
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment40
Start date6 April 2018
Primary completion1 November 2018
Estimated completion16 November 2018
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Oxford University Hospitals NHS Trust

Who can join

18 and older, any sex, with Ureter Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phase 1/2a study, second in-man utilising IRDye800BK in ureteric identification using fluorescence throughout abdominal surgery. Study is open label, non-randomised prospective study.

Publications & conference data

5 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. Multispectral Imaging Using Fluorescent Properties of Indocyanine Green and Methylene Blue in Colorectal Surgery-Initial Experience.
    Polom W, Migaczewski M, Skokowski J, Swierblewski M, et al · · 2022 · cited 16× · PMID 35054062 · DOI 10.3390/jcm11020368
  4. 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
  5. Role of near-infrared fluorescence in colorectal surgery.
    Zocola E, Meyer J, Christou N, Liot E, et al · · 2021 · cited 10× · PMID 34497444 · DOI 10.3748/wjg.v27.i31.5189

Verify or expand the search:

Other recruiting trials for Ureter Injury

Currently open trials in the same condition.

Other Oxford University Hospitals NHS Trust trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03387410.

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