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Clinical Trials/NCT05769244
NCT05769244
Completed
Not Applicable

Near Infrared Spectroscopy and Testicular Torsion in Children

Centre Hospitalier Universitaire, Amiens1 site in 1 country55 target enrollmentJune 24, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diagnostic Test
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
55
Locations
1
Primary Endpoint
mean tissue oxygenation percentage (NIRS measurements) of the both testicles for boys with scrotal pain
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 24, 2020
End Date
September 12, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

mean tissue oxygenation percentage (NIRS measurements) of the both testicles for boys with scrotal pain

Time Frame: one day

Near-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 pain

Time Frame: one day

Near-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 testicles for healthy boys

Time Frame: one day

Near-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

Study Sites (1)

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