Ureter Identification With IRDye 800BK

NHS Trust

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ureter Injury

Treatments

Drug: Intravenous IRDye 800BK

Study type

Interventional

Funder types

Other

Identifiers

NCT03387410

12932

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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