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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
74
BC Children's Hospital
Vancouver, British Columbia, Canada
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).
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)
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).
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).
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
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).
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