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Near Infrared Spectroscopy and Testicular Torsion in Children

Near Infrared Spectroscopy and Testicular Torsion in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05769244
Acronym
SPIRETTE
Enrollment
55
Registered
2023-03-15
Start date
2020-06-24
Completion date
2023-09-12
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Diagnosis, Diagnostic Test, NIRS, Testicular Torsion

Brief summary

NIRS estimates tissue saturation of oxygenation in tissue beds. Animals studies suggested that transscrotal NIRS measurements can quantify testicular hypoxia and differentiate between torsed and non torsed testicles. The results of human studies are not conclusive. The hypothesis is that the difference in NIRS values between torsed and healthy testicles would not be zero and that this difference would be zero in control group and that NIRS could help to detect rapidly a TT Testicular torsion (TT) is a functional emergency. The diagnosis is sometimes difficult to make. No paraclinical examination can eliminate it with certainty. The investigators aimed to evaluate the interest of transscrotal near-infrared spectroscopy (NIRS) for the diagnosis of TT of child

Interventions

NIRS measurements will be performed on each testicle on a group of healthy boys and on a group of boys under 18 years consulting to emergency for scrotal pain

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Step 1: healthy boys between 0 and 16 years old * Step 2Testicular pain group (Group 1 and 2): boy under 18 years, testicular pain

Exclusion criteria

* cutaneous scrotal lesion, * fever (for the control group), * hypertension

Design outcomes

Primary

MeasureTime frameDescription
mean tissue oxygenation percentage (NIRS measurements) of the testicles for healthy boysone dayNear-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain. Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients
mean tissue oxygenation percentage (NIRS measurements) of the both testicles for boys with scrotal painone dayNear-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain. Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients
mean tissue oxygenation percentage (NIRS measurements) between both testicles for boys with scrotal painone dayNear-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain. Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026