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Validation of ICG to Identify the Urethra During Rectal Surgery

NCT03204201 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-08-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Indocyanine Green Solution

Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Roel Hompes, MD · Consultant Colorectal Surgeon

  • Thomas Barnes, MBChB · Clinical Research Fellow

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2018-07-01
Completion
2018-08-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204201 on ClinicalTrials.gov