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NCT Number: NCT07548086

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

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.

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Key information

Conditions

Testicular Torsion Genital Diseases Genital Diseases, Male Healthy Male Urogenital Diseases Spermatic Cord Torsion Urogenital Diseases

Age range

1 month–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

SR-NIRS

Device

Feasibility in Healthy Control

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.

    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)

  2. 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.

Secondary outcomes

  1. 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.

  2. 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).

  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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Maryam Noparast, MD, MSc

CONTACT

[email protected]

604-875-2734

Sponsors and collaborators

Lead sponsor

Kourosh Afshar

Other

Registry information

Official study title

Feasibility and Exploratory Evaluation of Spatially-resolved Near-infrared Spectroscopy (SR-NIRS) in Testicular Torsion

Acronym: SR-NIRS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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