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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
Fluorescence of the ureter using IRDye 800BK
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
Change of signal to background measurements and visualisation of fluorescence in the ureter
Signal to background is an objective measurement of fluorescence signal
Time frame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
Change in subjective assessment of ureter visualisation with and without fluorescence
Time frame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
Number of adverse events related to IRDye 800BK administration
Time frame: 30 days post administration
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