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

April 20, 2026 updated by: Kourosh Afshar

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Controls
Part 1 study, SR-NIRS signal acquisition from testis and ipsilateral upper thigh, each for one minute
Device: SR-NIRS
Feasibility in Healthy Control
Device: SR-NIRS
Cases
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
Feasibility in Healthy Control
Device: SR-NIRS
Cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
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.
Day1; The outcome is measured immediately after the completion of the NIRS test (intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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).
Descriptive characterization of SR-NIRS-derived oxygenation and perfusion parameters in clinically unaffected testes and reference site (ipsilateral thigh).
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).
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).
Any adverse events (based on Common Terminology Criteria for Adverse Events (CTCAE) Version 5).
Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kourosh Afshar

Investigators

  • Principal Investigator: Kourosh Afshar, MD, FRCSC, University of British Columbia, Department of Urologic Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H26-00691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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