Torsion TestisPhase 4NCT07545278
Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?
A Phase 4 study testing Indocyanine green fluorescence injection and near infra red spectroscopy image capture in people with Torsion Testis and Scrotum Disease, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Testicular torsion is a time critical condition for children and young people (CYP). It is difficult to diagnose without an operation. Missing it means the child will lose a testicle. Read more about this study
- Who is it for?
- Ages Up to 19 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Torsion Testis, Scrotum Disease
- What is being tested?
- Indocyanine green fluorescence injection and near infra red spectroscopy image capture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Apr 2025to 30 Jun 2026
- Phase
- Phase 4
- 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 Up to 19 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All children presenting with testicular pain, being taken to theatre for scrotal exploration at Sheffield Children's NHS Foundation Trust. Aged 0-19 years of age.
Who cannot join
- Children with any allergy to contrast medium or iodine will be excluded.
- Any family or young person > age 13 years refusing consent.
- Children without a GP will not be exempt from recruitment. No information is required from community care.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's Hospital
Sheffield, South Yorkshire, S10 2TH
About this study
Official title: Assessment of Diagnostic Accuracy of Indocyanine Green Fluorescence Imaging in Children and Young People With Testicular Pain Requiring Surgical Exploration Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?
Testicular torsion is a time critical condition for children and young people (CYP). It is difficult to diagnose without an operation. Missing it means the child will lose a testicle. There are no good diagnostic tests, only tests that delay the child's journey to theatre, which puts them at further risk of losing the testicle. Most boys with a painful testicle get a surgical exploration to see if it is torsion and to twist and fix it. Up to 85% of children having surgery will not have torsion. They will have something they didn't need surgery for. We want to see whether a new, low risk, fast investigation could be used to diagnose the problem, meaning no torsions are missed and less children have unnecessary surgery.
Read the detailed description
Children being taken to theatre for testicular pain for suspected torsion over a 1-year period will be registered prospectively. A clerking proforma will be utilised for all children with testicular pain with details including duration of pain, presentation pathway, address, dob, ethnicity, tanner stage, comorbidities and the standard questions in a clerking for children with testicular pain.
Children proceeding to theatre will be consented for injection of ICG within their consent for surgery by appropriately GCP trained and delegated study team members. . Age-appropriate information leaflets will be provided, and consent and assent taken as appropriate from potential participants and their guardians (if required). Children having consented will have allocation of a participant ID. They will then proceed for injection of indocyanine green after safe establishment of anaesthetic and with the surgical team present. After 5 minutes an image of the CYP scrotum will be taken prior to prepping. The images are taken using a specialist near infra-red (NIR) camera. This is a new imaging system for SCNFT, but technology used at Sheffield Teaching Hospitals and in other children's hospitals in the country. This NIR camera head requires a new stacker for theatres but is fully compatible with our systems. These images will be taken under the category ICG scrotum on the theatre tablets. These will be stored on a tablet and printed from the theatre stack and exported to the server as standard practice for all images in the surgical department. Participant ID will be attached to the images and the images will be stored in the electronic notes. Process in theatre in described in Appendix 3.
The findings at surgery will be recorded and describe torsion, degree of torsion, colour at surgery, bleed time. A second image will be taken in cases of torsion. Appendix 2, form 2 describes data collection taken in theatre. Once detorted a second image will be taken and processed similarly. Fixation will proceed as standard practice.
There will be no change in the patient pathway for acute scrotum. Any adverse events will be monitored via immediate reporting of side effects to PI Caroline MacDonald, see Appendix for theatre protocol.
All children with torsion will have a follow up phone call at 12 months to check testicular status and any adverse events. Those without torsion do not need long term follow up, as we do not expect late atrophy.
Early analysis of ICG findings with surgical findings will be undertaken. A study investigator (BMedSci Student from University of Sheffield), independent of the surgical or radiology team, blinded to surgical outcomes will assess the printed and electronic images and assess for dichotomous and graduated fluorescence findings. These then will be compared to surgical outcomes and diagnostic accuracy evaluated using standard diagnostic accuracy calculations. Outcomes will be compared by time to presentation, age and racial identification.
- Conditions
- Torsion Testis, Scrotum Disease
- Being tested
- Indocyanine green fluorescence injection and near infra red spectroscopy image capture
- Keywords
- torsion of testis, indocyanine green, acute scrotrum
- Medical subject headings
- Spermatic Cord Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green fluorescence injection and near infra red spectroscopy image captureDiagnostic test
As above
| Study group | Role | What they receive |
|---|---|---|
| Investigation of diagnostic accuracy of ICG | Other | all children Receives: Diagnostic Test: Indocyanine green fluorescence injection and near infra red spectroscopy image capture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of ICG for testicular torsion as compared to non-torsion diagnosis.
Diagnostic accuracy of ICG for testicular torsion as compared to non-torsion diagnosis at surgery
Measured: 12 months
Secondary outcomes (1)
ICG to predict late testicular atrophy
ICG to predict late testicular atrophy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start30 Apr 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Torsion TestisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- All children identified going to theatre will be recruited. Calculating diagnostic accuracy compared to findings at theatre
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545278
- Sponsor's protocol ID
- SCH-2769
- Status last verified
- Jul 2026
- First submitted
- 15 Apr 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be anonymised. Dataset will be made available on mendeley database
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Diagnostic Accuracy of Indocyanine Green Fluorescence Imaging in Children and Young People With Testicular Pain Requiring Surgical Exploration Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?
- ClinicalTrials.gov ID
- NCT07545278
- Acronym / sponsor ID
- SCH-2769
- Conditions
- Torsion Testis, Scrotum Disease
- Keywords
- torsion of testis, indocyanine green, acute scrotrum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 Apr 2026 (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.
Testicular torsion is a time critical condition for children and young people (CYP). It is difficult to diagnose without an operation. Missing it means the child will lose a testicle. There are no good diagnostic tests, only tests that delay the child's journey to theatre, which puts them at further risk of losing the testicle. Most boys with a painful testicle get a surgical exploration to see if it is torsion and to twist and fix it. Up to 85% of children having surgery will not have torsion. They will have something they didn't need surgery for. We want to see whether a new, low risk, fast investigation could be used to diagnose the problem, meaning no torsions are missed and less children have unnecessary surgery.
Detailed description
Children being taken to theatre for testicular pain for suspected torsion over a 1-year period will be registered prospectively. A clerking proforma will be utilised for all children with testicular pain with details including duration of pain, presentation pathway, address, dob, ethnicity, tanner stage, comorbidities and the standard questions in a clerking for children with testicular pain.
Children proceeding to theatre will be consented for injection of ICG within their consent for surgery by appropriately GCP trained and delegated study team members. . Age-appropriate information leaflets will be provided, and consent and assent taken as appropriate from potential participants and their guardians (if required). Children having consented will have allocation of a participant ID. They will then proceed for injection of indocyanine green after safe establishment of anaesthetic and with the surgical team present. After 5 minutes an image of the CYP scrotum will be taken prior to prepping. The images are taken using a specialist near infra-red (NIR) camera. This is a new imaging system for SCNFT, but technology used at Sheffield Teaching Hospitals and in other children's hospitals in the country. This NIR camera head requires a new stacker for theatres but is fully compatible with our systems. These images will be taken under the category ICG scrotum on the theatre tablets. These will be stored on a tablet and printed from the theatre stack and exported to the server as standard practice for all images in the surgical department. Participant ID will be attached to the images and the images will be stored in the electronic notes. Process in theatre in described in Appendix 3.
The findings at surgery will be recorded and describe torsion, degree of torsion, colour at surgery, bleed time. A second image will be taken in cases of torsion. Appendix 2, form 2 describes data collection taken in theatre. Once detorted a second image will be taken and processed similarly. Fixation will proceed as standard practice.
There will be no change in the patient pathway for acute scrotum. Any adverse events will be monitored via immediate reporting of side effects to PI Caroline MacDonald, see Appendix for theatre protocol.
All children with torsion will have a follow up phone call at 12 months to check testicular status and any adverse events. Those without torsion do not need long term follow up, as we do not expect late atrophy.
Early analysis of ICG findings with surgical findings will be undertaken. A study investigator (BMedSci Student from University of Sheffield), independent of the surgical or radiology team, blinded to surgical outcomes will assess the printed and electronic images and assess for dichotomous and graduated fluorescence findings. These then will be compared to surgical outcomes and diagnostic accuracy evaluated using standard diagnostic accuracy calculations. Outcomes will be compared by time to presentation, age and racial identification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All children identified going to theatre will be recruited. Calculating diagnostic accuracy compared to findings at theatre
| Arm | Type | Receives |
|---|---|---|
| Investigation of diagnostic accuracy of ICG | Other | Diagnostic Test: Indocyanine green fluorescence injection and near infra red spectroscopy image captureall children |
Who may qualify
- Ages
- Up to 19 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children presenting with testicular pain, being taken to theatre for scrotal exploration at Sheffield Children's NHS Foundation Trust. Aged 0-19 years of age.
Key exclusion criteria (3 listed)
- Children with any allergy to contrast medium or iodine will be excluded.
- Any family or young person > age 13 years refusing consent.
- Children without a GP will not be exempt from recruitment. No information is required from community care.
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 fluorescence injection and near infra red spectroscopy image captureAs above | Diagnostic test | Investigation of diagnostic accuracy of ICG |
Primary outcome
Diagnostic accuracy of ICG for testicular torsion as compared to non-torsion diagnosis.
Time frame: 12 months
Diagnostic accuracy of ICG for testicular torsion as compared to non-torsion diagnosis at surgery
1 secondary outcome
ICG to predict late testicular atrophy
Time frame: 24 months
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 31 Jul 2026.
- Individual participant dataSharing planned: No. All data will be anonymised. Dataset will be made available on mendeley database
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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 4 study testing Indocyanine green fluorescence injection and near infra red spectroscopy image capture in people with Torsion Testis and Scrotum Disease, run by Sheffield Children's NHS Foundation 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 1 inclusion and 3 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 31 Jul 2026. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Diagnostic accuracy of ICG for testicular torsion as compared to non-torsion diagnosis. (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 31 Jul 2026.