Urethra InjuryPhase 1/2NCT03204201
Validation of ICG to Identify the Urethra During Rectal Surgery
A Phase 1/2 study testing Indocyanine Green Solution in people with Urethra Injury and Rectal Cancer, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urethra Injury, Rectal Cancer, Surgery
- What is being tested?
- Indocyanine Green Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jul 2017to 1 Aug 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participant has an allergy to iodine or ICG
- Known liver failure
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE
About this study
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
- Urethra Injury, Rectal Cancer, Surgery
- Being tested
- Indocyanine Green Solution
- Keywords
- Fluorescence
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green SolutionDrug
Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant
| Study group | Role | What they receive |
|---|---|---|
| Urethral instillation of ICG | Experimental | Urethral instillation of indocyanine green (ICG) Receives: Drug: Indocyanine Green Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of urethras identified under white light and fluorescence
Measured: 1 day
Secondary outcomes (4)
Signal to background ratios between cohorts of patients with varying doses of ICG
Measured: 1 day
Subjective assessment of usefulness of technology during operative procedure
Measured: 1 day
Length of time of interruption in operative procedure to perform trial intervention
Measured: 1 day
Number of adverse events related to trial intervention
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start11 Jul 2017
- Primary completion1 Jul 2018
- Study completion1 Aug 2018
Why it stopped: Technique failed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethra InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, Thomas Barnes, Oxford University Hospitals NHS Trust
- Investigators
- Roel Hompes, MD, Principal investigator, Consultant Colorectal SurgeonThomas Barnes, MBChB, Principal investigator, Clinical Research Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204201
- Sponsor's protocol ID
- 12748
- Status last verified
- Aug 2019
- First submitted
- 28 Jun 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data to be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of ICG to Identify the Urethra During Rectal Surgery
- ClinicalTrials.gov ID
- NCT03204201
- Acronym / sponsor ID
- 12748
- Conditions
- Urethra Injury, Rectal Cancer, Surgery
- Keywords
- Fluorescence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technique failed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urethral instillation of ICG | Experimental | Drug: Indocyanine Green SolutionUrethral instillation of indocyanine green (ICG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Participant has an allergy to iodine or ICG
- Known liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine Green SolutionUrethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant | Drug | Urethral instillation of ICG |
Primary outcome
Number of urethras identified under white light and fluorescence
Time frame: 1 day
4 secondary outcomes
Signal to background ratios between cohorts of patients with varying doses of ICG
Time frame: 1 day
Subjective assessment of usefulness of technology during operative procedure
Time frame: 1 day
Length of time of interruption in operative procedure to perform trial intervention
Time frame: 1 day
Number of adverse events related to trial intervention
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Technique failed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No. No individual participant data to be shared
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A Comparative Study of the Antibacterial Effects of Two Preoperative Hair Removal Methods in Male Patients With Urethral Stricture
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roel Hompes, MD principal investigator
Consultant Colorectal Surgeon
Thomas Barnes, MBChB principal investigator
Clinical Research Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Indocyanine Green Solution in people with Urethra Injury and Rectal Cancer, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Technique failed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of urethras identified under white light and fluorescence (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.