Ureter Identification With IRDye 800BK

NCT ID: NCT03387410

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2018-11-16

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.

Conditions

Ureter Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intravenous IRDye 800BK

Patients undergoing laparoscopic bowel resection \& laparoscopic donor nephrectomy

Group Type: EXPERIMENTAL

Intravenous IRDye 800BK

Intervention Type: DRUG

Fluorescence of the ureter using IRDye 800BK

Interventions

Intravenous IRDye 800BK

Fluorescence of the ureter using IRDye 800BK

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Thomas Barnes

Clinical Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

12932

Identifier Type: -

Identifier Source: org_study_id