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Not yet recruitingNCT07548086SR-NIRSUpdated Apr 23, 2026

Light-Based Monitoring (SR-NIRS) for Suspected Testicular Torsion in Children

An interventional study of SR-NIRS and SR-NIRS in Testicular Torsion and Healthy, sponsored by Kourosh Afshar. Not yet recruiting at 1 site in Canada. Open to male participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Kourosh Afshar · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Non-randomized
Ages
1 Month to 18 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Testicular Torsion
  • Healthy

Keywords

  • Feasibility study
  • Exploratory Study
  • Near-infrared spectroscopy
  • Pediatric Urology
03

In context

Lead sponsor

This is the only study on the registry with Kourosh Afshar as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    Healthy Controls

    Part 1 study, SR-NIRS signal acquisition from testis and ipsilateral upper thigh, each for one minute

    Device: SR-NIRS

  • Experimental
    Testicular Torsion Cases

    Part 2 study, SR-NIRS signal recording of at least one minute from affected testis, contralateral testis, and upper thigh.

    Device: SR-NIRS

Interventions

  • DeviceSR-NIRS

    Feasibility in Healthy Control

  • DeviceSR-NIRS

    Cases

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).

  2. 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.

    Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (intervention)

Secondary outcomes

  1. 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.

    Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).

  2. 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).

    Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).

  3. 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).

  4. 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).

    Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2026
First posted
Apr 23, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2029
CompletionEst.
Sep 1, 2029
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07548086
Lead sponsor
Kourosh Afshar
Responsible party
Kourosh Afshar (Professor, Urologic Sciences, Faculty of Medicine, University of British Columbia, University of British Columbia) — Sponsor-investigator
First posted
Apr 23, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2029 (estimated)
Completion
Sep 1, 2029 (estimated)
Last update
Apr 23, 2026

Study contacts

Maryam Noparast, MD, MSc
Contact
maryam.noparast@cw.bc.ca
604-875-2734
Kourosh Afshar, MD, FRCSC
principal investigator · University of British Columbia, Department of Urologic Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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