Validation of ICG to Identify the Urethra During Rectal Surgery

Sponsor

Oxford University Hospitals NHS Trust (Other)

Overall Status

Terminated

CT.gov ID

NCT03204201

Collaborator

University of Oxford (Other)

Enrollment

Location

Arm

12.7

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urethra Injury Rectal Cancer Surgery	Drug: Indocyanine Green Solution	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Validation of ICG to Identify the Urethra During Rectal Surgery

Actual Study Start Date :

Jul 11, 2017

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of urethras identified under white light and fluorescence [1 day]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire	United Kingdom	OX3 7LE

Sponsors and Collaborators

Oxford University Hospitals NHS Trust
University of Oxford

Investigators

Principal Investigator: Roel Hompes, MD, Consultant Colorectal Surgeon
Principal Investigator: Thomas Barnes, MBChB, Clinical Research Fellow

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Barnes, Clinical Research Fellow, Oxford University Hospitals NHS Trust

ClinicalTrials.gov Identifier:

NCT03204201

Other Study ID Numbers:

12748

First Posted:

Jun 29, 2017

Last Update Posted:

Aug 13, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Barnes, Clinical Research Fellow, Oxford University Hospitals NHS Trust

Fluorescence

Additional relevant MeSH terms:

Rectal Neoplasms

Study Results

No Results Posted as of Aug 13, 2019