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

(SR-NIRS Trial)

Overseen By Maryam Noparast, MD, MSc

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Kourosh Afshar

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Kourosh Afshar, MD, FRCSC

Principal Investigator

University of British Columbia, Department of Urologic Sciences

Are You a Good Fit for This Trial?

Inclusion Criteria

* Inclusion Criteria

* Boys aged 1 month to 18 years.

* Presenting to the urology clinic with non-testicular complaints.

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Testicular Torsion Cases Experimental Treatment 1 Intervention

Part 2 study, SR-NIRS signal recording of at least one minute from affected testis, contralateral testis, and upper thigh.

Group II: Healthy Controls Experimental Treatment 1 Intervention

Part 1 study, SR-NIRS signal acquisition from testis and ipsilateral upper thigh, each for one minute

Who Is Running the Clinical Trial?

Kourosh Afshar

Lead Sponsor