Validation of ICG to Identify the Urethra During Rectal Surgery

August 10, 2019 updated by: Thomas Barnes, Oxford University Hospitals NHS Trust
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Urethral instillation of ICG
Urethral instillation of indocyanine green (ICG)
Drug: Indocyanine Green Solution
Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of urethras identified under white light and fluorescence
Time Frame: 1 day
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Hospitals NHS Trust

Collaborators

University of Oxford

Investigators

  • Principal Investigator: Roel Hompes, MD, Consultant Colorectal Surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2017

Primary Completion (ACTUAL)

July 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (ACTUAL)

June 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 10, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12748

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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