Ureter Identification With IRDye 800BK | NCT03387410

NCT03387410

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
University of Oxford	OTHER

Label	Type	Description	Intervention Names
Intravenous IRDye 800BK	Experimental	Patients undergoing laparoscopic bowel resection & laparoscopic donor nephrectomy	Drug: Intravenous IRDye 800BK

Name	Type	Description	Arm Group Labels	Other Names
Intravenous IRDye 800BK	Drug	Fluorescence of the ureter using IRDye 800BK	Intravenous IRDye 800BK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of signal to background measurements and visualisation of fluorescence in the ureter	Signal to background is an objective measurement of fluorescence signal	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		0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose

Measure	Description	Time Frame
Number of adverse events related to IRDye 800BK administration		30 days post administration

Eligibility Module

Eligibility Criteria

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

Exclusion criteria for transplant recipients

• Female who is pregnant, lactating, or planning pregnancy throughout the trial