Ureter Injury
Conditions
Keywords
Laparoscopic surgery, Fluorescence
Brief summary
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.
Interventions
DRUGIntravenous IRDye 800BK
Fluorescence of the ureter using IRDye 800BK
Sponsors
University of Oxford
Oxford University Hospitals NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Group A & B participants) * Participant is willing and able to give informed consent for participation in the trial. * Male or Female, aged 18 years or above. * Undergoing elective laparoscopic abdominal surgery or undergoing planned laparoscopic donor nephrectomy (donation) * Participant has available laboratory and ECG results within 3 months of enrolment. * Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter * In the Investigator's opinion, is able and willing to comply with all trial requirements. * Group A only: Participant is undergoing laparoscopic colorectal surgery * Group B only: Participant is undergoing laparoscopic donor nephrectomy
Exclusion criteria
(Group A & B participants) The participant may not enter the trial if ANY of the following apply: * Female participant who is pregnant, lactating or planning pregnancy throughout the trial. * Significant renal impairment (eGFR of under 50mL/min/1,73m2) * Significant liver impairment as defined as: * AST \> 3.0 x ULN or * ALT \> 3.0 x ULN or * Total serum bilirubin \> 1.5 x ULN * Participants involved with another research trial involving an unlicensed medicine in the past 12 weeks. * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. * Known allergy to D-Mannitol or citric acid * Group B Only: Laparoscopic donor nephrectomy patients in whom the kidney recipient has refused participation or if the recipient is being transplanted in another transplant centre Inclusion criteria for transplant recipients * Participant must be willing and able to give informed consent for trial participation * Male or female aged 18 years or over * Is able and willing to comply with all trial requirements * Receiving a kidney from a participant recruited to this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of signal to background measurements and visualisation of fluorescence in the ureter | 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose | Signal to background is an objective measurement of fluorescence signal |
| Change in subjective assessment of ureter visualisation with and without fluorescence | 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events related to IRDye 800BK administration | 30 days post administration |
Countries
United Kingdom
Outcome results
None listed