Healthy, Testicular Torsion
Conditions
Keywords
Feasibility study, Exploratory Study, Near-infrared spectroscopy, Pediatric Urology
Brief 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.
Interventions
DEVICESR-NIRS
Feasibility in Healthy Control
Sponsors
Kourosh Afshar
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
The person interpreting SR-NIRS signals is blind to the final diagnosis of the participants in part 2 (testicular torsion vs other).
Intervention model description
This is a sequential design. Phase 1 is for determination of feasibility and phase 2 for assessment of diagnostic ability/accuracy.
Eligibility
Sex/Gender
MALE
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Part 2- Difference in TOI between torsion and non-torsion presentation in children with acute scrotum. | 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. |
| Part 1- Reference ranges for SR-NIRS-derived parameters (HbO₂, HHb, THb, TOI, RTPI) in children with unaffected testis. | 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). |
| Part 2-Differences in SR-NIRS tissue oxygenation parameters (Oxygenated hemoglobin (O₂Hb), Deoxygenated hemoglobin (HHb), Total hemoglobin (THb)) between children with and without torsion. | 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 | 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). |
Countries
Canada
Contacts
CONTACTMaryam Noparast, MD, MSc
PRINCIPAL_INVESTIGATORKourosh Afshar, MD, FRCSC
University of British Columbia, Department of Urologic Sciences
Outcome results
None listed