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SR-NIRS monitors blood flow in children's testicular torsion

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Summary

A clinical trial (NCT07548086) sponsored by the NIH has been registered to evaluate whether Spatially Resolved Near-Infrared Spectroscopy (SR-NIRS) can reliably measure blood flow and oxygen levels in the testicles of children aged 1 month to 18 years. The study has two parts: Part 1 is a feasibility study enrolling 24 healthy children, and Part 2 is an exploratory study enrolling 50 children with and without testicular torsion. Participants will have a small probe placed on the skin over the testicle(s) and thigh for a brief measurement during a single visit; the results will not affect clinical diagnosis or treatment.

“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.”

NIH , verbatim from source
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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

NIH has registered a new clinical trial on ClinicalTrials.gov to study whether SR-NIRS can serve as a non-invasive tool for measuring testicular blood flow and oxygen levels in children. Part 1 enrolls 24 healthy boys to establish measurement feasibility, while Part 2 enrolls 50 boys with and without testicular torsion to explore measurement differences. Participants undergo a single visit with a probe placed on the testicle and thigh. The study explicitly states it will not affect clinical diagnosis or treatment decisions, and results are intended to guide future research.

Healthcare providers and clinical investigators involved in pediatric urology or emergency care should be aware of this trial as it may inform future non-invasive assessment approaches for testicular torsion. Trial sponsors and medical device manufacturers developing near-infrared spectroscopy applications may find these results relevant to product development pipelines.

Archived snapshot

Apr 24, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

N/A NCT07548086 Kind: NA Apr 23, 2026

Abstract

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

Interventions: SR-NIRS, SR-NIRS

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Last updated

Classification

Agency
NIH
Published
April 23rd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Docket
NCT07548086

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Medical device research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Public Health

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