Ureter Identification With IRDye 800BK

Phase 1

Completed

• Conditions: Ureter Injury
• Interventions: Drug: Intravenous IRDye 800BK

• Registration Number: NCT03387410
• Lead Sponsor: Oxford University Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2018-01-02
• Study Start: 2018-04-06
• Status Verified: 2018-11
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-16
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous IRDye 800BK	Intravenous IRDye 800BK	Patients undergoing laparoscopic bowel resection \& laparoscopic donor nephrectomy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of adverse events related to IRDye 800BK administration	30 days post administration

Trial Locations

Locations (1)

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, Oxfordshire, United Kingdom