Health TrialsbyHealthPanel

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

ConditionsTesticular TorsionHealthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age1-18
SponsorKourosh Afshar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Boys aged 1 month to 18 years.

Presenting to the urology clinic with non-testicular complaints.

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.

Disqualifiers

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

Boys with a history of testicular surgery, scrotal surgery, inguinal hernia, hydrocele, varicocele, or undescended testicle.

Unable or unwilling to provide consent/assent.

Trial design

Design model

Sequential

Treatments tested in this trial

  • SR-NIRS

    Device

    Feasibility in Healthy Control

  • SR-NIRS

    Device

    Cases

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Healthy ControlsExperimental treatment 1 intervention
Group B: Testicular Torsion CasesExperimental treatment 1 intervention

Trial outcomes

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kourosh Afshar

Lead sponsor

University of British Columbia

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: