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

NCT07548086 | Not Yet Recruiting

• 1 other identifier: H26-00691
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Torsion; Healthy

Keywords

Feasibility study; Exploratory Study; Near-infrared spectroscopy; Pediatric Urology

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Day1; The outcome is measured immediately after the completion of the NIRS test (intervention)

Secondary Outcomes (4)

• 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).

• 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).

• 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).

Study Arms (2)

Healthy Controls

EXPERIMENTAL

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

Device: SR-NIRS

Testicular Torsion Cases

EXPERIMENTAL

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

Device: SR-NIRS

Interventions

SR-NIRS DEVICE

Feasibility in Healthy Control

Healthy Controls

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kourosh Afshar: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Spermatic Cord Torsion

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kourosh Afshar, MD, FRCSC

  University of British Columbia, Department of Urologic Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Noparast, MD, MSc

CONTACT

604-875-2734; maryam.noparast@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The person interpreting SR-NIRS signals is blind to the final diagnosis of the participants in part 2 (testicular torsion vs other).
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Urologic Sciences, Faculty of Medicine, University of British Columbia

Model Details: This is a sequential design. Phase 1 is for determination of feasibility and phase 2 for assessment of diagnostic ability/accuracy.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)