Validation of ICG to Identify the Urethra During Rectal Surgery

Phase 1

Terminated

• Conditions: Urethra Injury; Rectal Cancer; Surgery
• Interventions: Drug: Indocyanine Green Solution

• Registration Number: NCT03204201
• Lead Sponsor: Oxford University Hospitals NHS Trust

Brief Summary

This is an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-06-28
• Study First Posted: 2017-06-29
• Study Start: 2017-07-11
• Primary Completion: 2018-07-01
• Study Completion: 2018-08-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-10
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 5

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.
• Male, aged 18 years or above.
• Undergoing low rectal surgery where the operating field will be close to the urethra

Exclusion Criteria

• Participant has an allergy to iodine or ICG
• Known liver failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urethral instillation of ICG	Indocyanine Green Solution	Urethral instillation of indocyanine green (ICG)

Primary Outcome Measures

Name	Time	Method
Number of urethras identified under white light and fluorescence	1 day

Secondary Outcome Measures

Name	Time	Method
Signal to background ratios between cohorts of patients with varying doses of ICG	1 day
Subjective assessment of usefulness of technology during operative procedure	1 day
Length of time of interruption in operative procedure to perform trial intervention	1 day
Number of adverse events related to trial intervention	30 days

Trial Locations

Locations (1)

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