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Not yet recruiting NCT07548086

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

No phase Interventional Testicular Torsion Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SR-NIRS, SR-NIRS.
Who it may be relevant to
Registry conditions: Testicular Torsion, Healthy. Basic parameters: 1 months — 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Feasibility and Exploratory Evaluation of Spatially-resolved Near-infrared Spectroscopy (SR-NIRS) in Testicular Torsion

Overview

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

  • Device SR-NIRS
    Feasibility in Healthy Control
  • Device SR-NIRS
    Cases

Primary outcome measures

  • 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. [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 [Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (intervention)]
Secondary outcome measures (4)
  • Part 2- Difference in TOI between torsion and non-torsion presentation in children with acute scrotum. [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. [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 [Time frame: Day1; The outcome is measured immediately after the completion of the NIRS test (the intervention).]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Canada · 1 center
  • BC Children's Hospital — Vancouver

Identifiers

NCT: NCT07548086 · H26-00691

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗