Back to resultsValidation of ICG to Identify the Urethra During Rectal Surgery
Primary Purpose
Urethra Injury, Rectal Cancer, Surgery
Status
Terminated
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Indocyanine Green Solution
Sponsored by
About this trial
This is an interventional other trial for Urethra Injury focused on measuring Fluorescence
Eligibility Criteria
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
Sites / Locations
- Oxford University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Urethral instillation of ICG
Arm Description
Urethral instillation of indocyanine green (ICG)
Outcomes
Primary Outcome Measures
Number of urethras identified under white light and fluorescence
Secondary Outcome Measures
Signal to background ratios between cohorts of patients with varying doses of ICG
Subjective assessment of usefulness of technology during operative procedure
Length of time of interruption in operative procedure to perform trial intervention
Number of adverse events related to trial intervention
Full Information
NCT ID
NCT03204201
First Posted
June 28, 2017
Last Updated
August 10, 2019
Sponsor
Oxford University Hospitals NHS Trust
Collaborators
University of Oxford
1. Study Identification
Unique Protocol Identification Number
NCT03204201
Brief Title
Validation of ICG to Identify the Urethra During Rectal Surgery
Official Title
Validation of ICG to Identify the Urethra During Rectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Technique failed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oxford University Hospitals NHS Trust
Collaborators
University of Oxford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethra Injury, Rectal Cancer, Surgery
Keywords
Fluorescence
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urethral instillation of ICG
Arm Type
Experimental
Arm Description
Urethral instillation of indocyanine green (ICG)
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green Solution
Intervention Description
Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant
Primary Outcome Measure Information:
Title
Number of urethras identified under white light and fluorescence
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Signal to background ratios between cohorts of patients with varying doses of ICG
Time Frame
1 day
Title
Subjective assessment of usefulness of technology during operative procedure
Time Frame
1 day
Title
Length of time of interruption in operative procedure to perform trial intervention
Time Frame
1 day
Title
Number of adverse events related to trial intervention
Time Frame
30 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roel Hompes, MD
Organizational Affiliation
Consultant Colorectal Surgeon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Barnes, MBChB
Organizational Affiliation
Clinical Research Fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data to be shared
Learn more about this trial
Validation of ICG to Identify the Urethra During Rectal Surgery
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