Testicular TorsionSR-NIRSNCT07548086
Light-Based Monitoring (SR-NIRS) for Suspected Testicular Torsion in Children
A study testing SR-NIRS in people with Testicular Torsion and Healthy, run by Kourosh Afshar at 1 site in Canada.
Trial summary
The goal of this clinical trial is to learn whether a non-invasive light-based test called Spatially Resolved Near-Infrared Spectroscopy (SR-NIRS) can measure blood flow and oxygen levels in the testicles of children. Read more about this study
- Who is it for?
- Ages 1 month to 18 years, men only
- Conditions the study is for
- Testicular Torsion, Healthy
- What is being tested?
- SR-NIRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 month to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Part 1:
- Boys aged 1 month to 18 years.
- Presenting to the urology clinic with non-testicular complaints.
- Part 2:
- Boys aged 1 month to 18 years.
- Presenting to the Emergency Room or urology clinic with acute scrotum, defined as a TWIST (Testicular Workup for Ischemia and Suspected Torsion) score ≥ 1.
Who cannot join
- Part 1:
- Any scrotal or testicular pathology, including hydrocele, inguinal hernia, undescended testicle, varicocele, or scrotal pain.
- History of testicular or scrotal surgery, except unilateral orchiopexy. Unable or unwilling to provide consent/assent
- Part 2:
- Boys with a history of testicular surgery, scrotal surgery, inguinal hernia, hydrocele, varicocele, or undescended testicle.
- Unable or unwilling to provide consent/assent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
BC Children's Hospital
Vancouver, British Columbia
Kourosh Afshar, MD, FRCSC, FAAP, 6048752734 ext. 1, kafashar@cw.bc.ca
Maryam Noparast, MD, MSC, maryam.noparast@cw.bc.ca
About this study
Official title: Feasibility and Exploratory Evaluation of Spatially-resolved Near-infrared Spectroscopy (SR-NIRS) in Testicular Torsion
The goal of this clinical trial is to learn whether a non-invasive light-based test called Spatially Resolved Near-Infrared Spectroscopy (SR-NIRS) can measure blood flow and oxygen levels in the testicles of children. The study includes boys aged 1 month to 18 years, including those without testicular problems (part 1) and those with sudden scrotal pain (part 2).
Testicular torsion is a condition where the blood supply to the testicle becomes twisted and reduced. This can lead to permanent damage if not treated quickly.
Read more
Current methods, such as ultrasound or surgery, may not always be immediately available and can sometimes lead to delays or unnecessary procedures. This study explores whether SR-NIRS can provide useful information about blood flow and oxygen levels in painful testicles of the children.
The main questions the study aims to answer are:
- Part 1 (Feasibility study, n=24) Can SR-NIRS reliably collect usable measurements in healthy children?
- Part 2 (exploratory study, n=50): Do SR-NIRS measurements differ between children with and without torsion?
Participants will:
- Have a small probe placed on the skin over the testicle(s) and thigh
- Undergo a brief measurement during a single visit
This study will not affect diagnosis or treatment. The results will help guide future research.
- Conditions
- Testicular Torsion, Healthy
- Being tested
- SR-NIRS
- Keywords
- Feasibility study, Exploratory Study, Near-infrared spectroscopy, Pediatric Urology
- 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.
SR-NIRSDevice
Feasibility in Healthy Control
SR-NIRSDevice
Cases
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | Part 1 study, SR-NIRS signal acquisition from testis and ipsilateral upper thigh, each for one minute Receives: Device: SR-NIRS |
| Testicular Torsion Cases | Experimental | Part 2 study, SR-NIRS signal recording of at least one minute from affected testis, contralateral testis, and upper thigh. Receives: Device: SR-NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1- Feasibility of the investigational SR-NIRS device for successful acquisition of interpretable tissue oxygenation and perfusion signals from pediatric testicular tissue in children with clinically unaffected testes.
Percentage of participants with at least 30 seconds of interpretable, artifact-free SR-NIRS recordings obtained at both measurement sites (testis and ipsilateral thigh reference site)
Measured: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).
Part 2- Difference in Regional Tissue Perfusion Index (RTPI) between torsion and non-torsion presentations in children with acute scrotum
Participant-level standardized RTPI, defined as:
[RTPI in affected testicle -RTPI in unaffected testicle/ RTPI in unaffected testicle] x100 will be compared between torsion and non-torsion groups.
Measured: Day1; The outcome is measured immediately after the completion of the NIRS test (intervention)
Secondary outcomes (4)
Part 2- Difference in TOI between torsion and non-torsion presentation in children with acute scrotum.
Participant-level standardized TOI difference, defined as [TOI in affected testicle -TOI in unaffected testicle/ TOI in unaffected testicle] x100 will be compared between torsion and non-torsion groups.
Measured: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).
Part 1- Reference ranges for SR-NIRS-derived parameters (HbO₂, HHb, THb, TOI, RTPI) in children with unaffected testis.
Descriptive characterization of SR-NIRS-derived oxygenation and perfusion parameters in clinically unaffected testes and reference site (ipsilateral thigh).
Measured: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).
Part 2-Differences in SR-NIRS tissue oxygenation parameters (Oxygenated hemoglobin (O₂Hb), Deoxygenated hemoglobin (HHb), Total hemoglobin (THb)) between children with and without torsion.
Measured: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).
Part 1 and Part 2-Safety and tolerability of SR-NIRS measurements
Any adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5).
Measured: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular TorsionStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a sequential design. Phase 1 is for determination of feasibility and phase 2 for assessment of diagnostic ability/accuracy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kourosh Afshar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kourosh Afshar, University of British Columbia
- Investigators
- Kourosh Afshar, MD, FRCSC, Principal investigator, University of British Columbia, Department of Urologic Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548086
- Sponsor's protocol ID
- H26-00691
- Acronym
- SR-NIRS
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Exploratory Evaluation of Spatially-resolved Near-infrared Spectroscopy (SR-NIRS) in Testicular Torsion
- ClinicalTrials.gov ID
- NCT07548086
- Acronym / sponsor ID
- SR-NIRS / H26-00691
- Conditions
- Testicular Torsion, Healthy
- Keywords
- Feasibility study, Exploratory Study, Near-infrared spectroscopy, Pediatric Urology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Kourosh AfsharUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 23 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.
The goal of this clinical trial is to learn whether a non-invasive light-based test called Spatially Resolved Near-Infrared Spectroscopy (SR-NIRS) can measure blood flow and oxygen levels in the testicles of children. The study includes boys aged 1 month to 18 years, including those without testicular problems (part 1) and those with sudden scrotal pain (part 2).
Testicular torsion is a condition where the blood supply to the testicle becomes twisted and reduced. This can lead to permanent damage if not treated quickly.
Current methods, such as ultrasound or surgery, may not always be immediately available and can sometimes lead to delays or unnecessary procedures. This study explores whether SR-NIRS can provide useful information about blood flow and oxygen levels in painful testicles of the children.
The main questions the study aims to answer are:
- Part 1 (Feasibility study, n=24) Can SR-NIRS reliably collect usable measurements in healthy children?
- Part 2 (exploratory study, n=50): Do SR-NIRS measurements differ between children with and without torsion?
Participants will:
- Have a small probe placed on the skin over the testicle(s) and thigh
- Undergo a brief measurement during a single visit
This study will not affect diagnosis or treatment. The results will help guide future research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a sequential design. Phase 1 is for determination of feasibility and phase 2 for assessment of diagnostic ability/accuracy.
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Device: SR-NIRSPart 1 study, SR-NIRS signal acquisition from testis and ipsilateral upper thigh, each for one minute |
| Testicular Torsion Cases | Experimental | Device: SR-NIRSPart 2 study, SR-NIRS signal recording of at least one minute from affected testis, contralateral testis, and upper thigh. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| SR-NIRSFeasibility in Healthy Control | Device | Healthy Controls |
| SR-NIRSCases | Device | Testicular Torsion Cases |
Primary outcome
Part 1- Feasibility of the investigational SR-NIRS device for successful acquisition of interpretable tissue oxygenation and perfusion signals from pediatric testicular tissue in children with clinically unaffected testes.
Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).
Percentage of participants with at least 30 seconds of interpretable, artifact-free SR-NIRS recordings obtained at both measurement sites (testis and ipsilateral thigh reference site)
Part 2- Difference in Regional Tissue Perfusion Index (RTPI) between torsion and non-torsion presentations in children with acute scrotum
Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (intervention)
Participant-level standardized RTPI, defined as: [RTPI in affected testicle -RTPI in unaffected testicle/ RTPI in unaffected testicle] x100 will be compared between torsion and non-torsion groups.
4 secondary outcomes
Part 2- Difference in TOI between torsion and non-torsion presentation in children with acute scrotum.
Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).
Part 1- Reference ranges for SR-NIRS-derived parameters (HbO₂, HHb, THb, TOI, RTPI) in children with unaffected testis.
Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).
Part 2-Differences in SR-NIRS tissue oxygenation parameters (Oxygenated hemoglobin (O₂Hb), Deoxygenated hemoglobin (HHb), Total hemoglobin (THb)) between children with and without torsion.
Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).
Part 1 and Part 2-Safety and tolerability of SR-NIRS measurements
Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- 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.
Kourosh Afshar, MD, FRCSC principal investigator
University of British Columbia, Department of Urologic Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SR-NIRS in people with Testicular Torsion and Healthy, run by Kourosh Afshar at 1 site in Canada.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 23 Apr 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryam Noparast, MD, MSc (604-875-2734, maryam.noparast@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1- Feasibility of the investigational SR-NIRS device for successful acquisition of interpretable tissue oxygenation and perfusion signals from pediatric testicular tissue in children with clinically unaffected testes. (time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).). 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 23 Apr 2026.