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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: 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 [Срок оценки: Day1; The outcome is measured immediately after the completion of the NIRS test (intervention)]

Вторичные конечные точки (4)

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

Критерии участия

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Канада · 1 центр

• BC Children's Hospital — Vancouver

Идентификаторы

NCT: NCT07548086 · H26-00691

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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