Fluorescence Guided SurgeryTRIUMPhNCT05111808
Feasibility Trial for Real-time Identification of the Ureters With a Methylene-blue
A study testing Methylene blue fluorescence in people with Fluorescence Guided Surgery, run by University College, London at 1 site in United Kingdom.
Trial summary
This is a non-randomized prospective, open label, single site study to evaluate the feasibility of recruitment for the use of an Investigational Endoscopic Fluorescence Imaging System, PINPOINT, in intraoperative bilateral visualization of ureters using intravenous injection of methylene blue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluorescence Guided Surgery
- What is being tested?
- Methylene blue fluorescence
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2020to 1 Oct 2023
- Phase
- Interventional
- 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
- 18 years of age or older
- Scheduled for a surgery where routine ureter identification is used
- Have signed an approved informed consent form for the study
- Be willing and able to comply with the study protocol
Who cannot join
- Known allergy or history of adverse reaction to methylene blue
- Taking an antidepressant including, but not limited, to selective and non-selective serotonin reuptake inhibitors, or a psychiatric medication
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Renal dysfunction defined as estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2
- Has participated in another investigational study within 30 days prior to surgery
- Pregnant or lactating subjects
- Subjects who, in the Investigator's and/or designee's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London
About this study
Official title: A Non-Randomized, Prospective, Open Label, Single-site Feasibility Trial for Real-time Identification of the Ureters With a Methylene-blue fluoroPhore
This is a non-randomized prospective, open label, single site study to evaluate the feasibility of recruitment for the use of an Investigational Endoscopic Fluorescence Imaging System, PINPOINT, in intraoperative bilateral visualization of ureters using intravenous injection of methylene blue. Feasibility of urine sample collection during surgery will also be assessed.
Read the detailed description
Background - During certain abdominal surgeries there is difficulty in finding the ureters, which act as a conduit for urine from the kidneys to the bladder. If the ureters are sectioned during surgery this causes great suffering for the patient and increased costs for the hospital and the National Health Service. Even experienced surgeons are at risk of causing this dreaded complication.
Methylene blue can emit a fluorescent signal and highlight the ureters in real time during surgical procedures. A study is necessary to evaluate the effectiveness of methylene blue fluorescence to identify the ureters during surgery.
Methods - In this study, patients undergoing abdominal surgery with high risk for ureter complications will be included. The feasibility of recruitment of these patients will be assessed using a screening log. Included patients with receive intraoperative methylene blue injection in increasing doses. Urine samples will be taken to establish the conversion of methylene blue to leucomethylene blue.
Expected results - the investigators expect to define the recruitment rate of the patient group of interest and to identify the causes for non recruitment. Secondary outcomes are ureteric identification and conversion of methylene blue to leucomethylene blue.
- Conditions
- Fluorescence Guided Surgery
- Being tested
- Methylene blue fluorescence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene blue fluorescenceDevice
IV administration of methylene blue, detection with deep infrared camera and light source
| Study group | Role | What they receive |
|---|---|---|
| Methyl Blue | Experimental | This group will receive intraoperative IV methyl blue Receives: Device: Methylene blue fluorescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment to study
Feasibility of recruitment to the study. This will be recorded in the screening log. The number of patients able partake in the study will be expressed as a percentage of the number of patients approached for consent.
Patients will be excluded if the do not meet the inclusion/exclusion criteria or do not consent.
Measured: 12 months
Secondary outcomes (2)
Rate of ureteric identification and signal intensity at defined time points
The operation will be paused and image switched to the Pinpoint camera at 5, 10, 15, 20, 30 and 40 minutes. The signal to background ratio will be calculated from the near infra-red images. This will allow us to quantify the fluorescence of methylene blue under near infra-red light.
Measured: 12 months
Percentage conversion of methylene blue to leucomethylene blue at defined time points
Urine samples will be taken at 10 minute intervals after the administration of methyl blue. The ratio of methylene blue to leucomethylene blue will be calculated at each of these stages to determine the likely rate of conversion rate.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start22 Jun 2020
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluorescence Guided SurgeryStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Manish Chand, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111808
- Sponsor's protocol ID
- 120726
- Acronym
- TRIUMPh
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Prospective, Open Label, Single-site Feasibility Trial for Real-time Identification of the Ureters With a Methylene-blue fluoroPhore
- ClinicalTrials.gov ID
- NCT05111808
- Acronym / sponsor ID
- TRIUMPh / 120726
- Conditions
- Fluorescence Guided Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 8 Nov 2021 (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 a non-randomized prospective, open label, single site study to evaluate the feasibility of recruitment for the use of an Investigational Endoscopic Fluorescence Imaging System, PINPOINT, in intraoperative bilateral visualization of ureters using intravenous injection of methylene blue. Feasibility of urine sample collection during surgery will also be assessed.
Detailed description
Background - During certain abdominal surgeries there is difficulty in finding the ureters, which act as a conduit for urine from the kidneys to the bladder. If the ureters are sectioned during surgery this causes great suffering for the patient and increased costs for the hospital and the National Health Service. Even experienced surgeons are at risk of causing this dreaded complication.
Methylene blue can emit a fluorescent signal and highlight the ureters in real time during surgical procedures. A study is necessary to evaluate the effectiveness of methylene blue fluorescence to identify the ureters during surgery.
Methods - In this study, patients undergoing abdominal surgery with high risk for ureter complications will be included. The feasibility of recruitment of these patients will be assessed using a screening log. Included patients with receive intraoperative methylene blue injection in increasing doses. Urine samples will be taken to establish the conversion of methylene blue to leucomethylene blue.
Expected results - the investigators expect to define the recruitment rate of the patient group of interest and to identify the causes for non recruitment. Secondary outcomes are ureteric identification and conversion of methylene blue to leucomethylene blue.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methyl Blue | Experimental | Device: Methylene blue fluorescenceThis group will receive intraoperative IV methyl blue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Scheduled for a surgery where routine ureter identification is used
- Have signed an approved informed consent form for the study
- Be willing and able to comply with the study protocol
Key exclusion criteria (7 listed)
- Known allergy or history of adverse reaction to methylene blue
- Taking an antidepressant including, but not limited, to selective and non-selective serotonin reuptake inhibitors, or a psychiatric medication
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Renal dysfunction defined as estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2
- Has participated in another investigational study within 30 days prior to surgery
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 |
|---|---|---|
| Methylene blue fluorescenceIV administration of methylene blue, detection with deep infrared camera and light source | Device | Methyl Blue |
Primary outcome
Rate of recruitment to study
Time frame: 12 months
Feasibility of recruitment to the study. This will be recorded in the screening log. The number of patients able partake in the study will be expressed as a percentage of the number of patients approached for consent. Patients will be excluded if the do not meet the inclusion/exclusion criteria or do not consent.
2 secondary outcomes
Rate of ureteric identification and signal intensity at defined time points
Time frame: 12 months
Percentage conversion of methylene blue to leucomethylene blue at defined time points
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- 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.
Manish Chand, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylene blue fluorescence in people with Fluorescence Guided Surgery, run by University College, London 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Pampiglione (02034567890, tom.pampiglione@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment to study (time frame: 12 months). 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 1 Nov 2022.