Ureter InjuryPhase 1/2NCT03387410
Ureter Identification With IRDye 800BK
A Phase 1/2 study testing Intravenous IRDye 800BK in people with Ureter Injury, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Phase 1/2a study, second in-man utilising IRDye800BK in ureteric identification using fluorescence throughout abdominal surgery. Study is open label, non-randomised prospective study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureter Injury
- What is being tested?
- Intravenous IRDye 800BK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 2018to 16 Nov 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 years or above.
- Undergoing elective laparoscopic abdominal surgery or undergoing planned laparoscopic donor nephrectomy (donation)
- Participant has available laboratory and ECG results within 3 months of enrolment.
- Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
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- Group A only: Participant is undergoing laparoscopic colorectal surgery
- Group B only: Participant is undergoing laparoscopic donor nephrectomy
- Participant must be willing and able to give informed consent for trial participation
- Male or female aged 18 years or over
- Is able and willing to comply with all trial requirements
- Receiving a kidney from a participant recruited to this study
Who cannot join
- The participant may not enter the trial if ANY of the following apply:
- Female participant who is pregnant, lactating or planning pregnancy throughout the trial.
- Significant renal impairment (eGFR of under 50mL/min/1,73m2)
- Significant liver impairment as defined as:
- AST > 3.0 x ULN or
- ALT > 3.0 x ULN or
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- Total serum bilirubin > 1.5 x ULN
- Participants involved with another research trial involving an unlicensed medicine in the past 12 weeks.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Known allergy to D-Mannitol or citric acid
- Group B Only: Laparoscopic donor nephrectomy patients in whom the kidney recipient has refused participation or if the recipient is being transplanted in another transplant centre
- Female who is pregnant, lactating, or planning pregnancy throughout the trial
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
Official title: Safety and Efficacy of IRDye 800BK in Ureter Identification Via Fluorescence Detection During Laparoscopic Abdominal Surgery
Phase 1/2a study, second in-man utilising IRDye800BK in ureteric identification using fluorescence throughout abdominal surgery. Study is open label, non-randomised prospective study.
- Conditions
- Ureter Injury
- Being tested
- Intravenous IRDye 800BK
- Keywords
- Laparoscopic surgery, Fluorescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous IRDye 800BKDrug
Fluorescence of the ureter using IRDye 800BK
| Study group | Role | What they receive |
|---|---|---|
| Intravenous IRDye 800BK | Experimental | Patients undergoing laparoscopic bowel resection \& laparoscopic donor nephrectomy Receives: Drug: Intravenous IRDye 800BK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of signal to background measurements and visualisation of fluorescence in the ureter
Signal to background is an objective measurement of fluorescence signal
Measured: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
Change in subjective assessment of ureter visualisation with and without fluorescence
Measured: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
Secondary outcomes (1)
Number of adverse events related to IRDye 800BK administration
Measured: 30 days post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start6 Apr 2018
- Primary completion1 Nov 2018
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureter 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
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387410
- Sponsor's protocol ID
- 12932
- Status last verified
- Nov 2018
- First submitted
- 18 Dec 2017
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of IRDye 800BK in Ureter Identification Via Fluorescence Detection During Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT03387410
- Acronym / sponsor ID
- 12932
- Conditions
- Ureter Injury
- Keywords
- Laparoscopic surgery, Fluorescence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 2 Jan 2018 (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.
Phase 1/2a study, second in-man utilising IRDye800BK in ureteric identification using fluorescence throughout abdominal surgery. Study is open label, non-randomised prospective study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous IRDye 800BK | Experimental | Drug: Intravenous IRDye 800BKPatients undergoing laparoscopic bowel resection \& laparoscopic donor nephrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 years or above.
- Undergoing elective laparoscopic abdominal surgery or undergoing planned laparoscopic donor nephrectomy (donation)
- Participant has available laboratory and ECG results within 3 months of enrolment.
- Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter
Key exclusion criteria (12 listed)
- Female participant who is pregnant, lactating or planning pregnancy throughout the trial.
- Significant renal impairment (eGFR of under 50mL/min/1,73m2)
- Significant liver impairment as defined as:
- Participants involved with another research trial involving an unlicensed medicine in the past 12 weeks.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
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 |
|---|---|---|
| Intravenous IRDye 800BKFluorescence of the ureter using IRDye 800BK | Drug | Intravenous IRDye 800BK |
Primary outcome
Change of signal to background measurements and visualisation of fluorescence in the ureter
Time frame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
Signal to background is an objective measurement of fluorescence signal
Change in subjective assessment of ureter visualisation with and without fluorescence
Time frame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose
1 secondary outcome
Number of adverse events related to IRDye 800BK administration
Time frame: 30 days post administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intravenous IRDye 800BK in people with Ureter Injury, 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 12 inclusion and 12 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: finished, as of the sponsor's last update on 19 Nov 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of signal to background measurements and visualisation of fluorescence in the ureter (time frame: 0, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 180, 240 minutes post dose). The study lists 2 primary outcomes in all. 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 19 Nov 2018; AzTrials last refreshed its copy on 28 Oct 2026.