NCT05769244

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

March 3, 2023

Last Update Submit

September 12, 2023

Conditions

Diagnostic TestNIRSTesticular TorsionDiagnosisChild

Outcome Measures

Primary Outcomes (3)

  • mean tissue oxygenation percentage (NIRS measurements) of the testicles for healthy boys

    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

    one day

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

    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

    one day

  • mean tissue oxygenation percentage (NIRS measurements) between both testicles for boys with scrotal pain

    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

    one day

Study Arms (3)

testicular torsion

EXPERIMENTAL
Other: near-infrared spectroscopy (NIRS)

other testicular pathology

ACTIVE COMPARATOR
Other: near-infrared spectroscopy (NIRS)

healthy patients

SHAM COMPARATOR
Other: near-infrared spectroscopy (NIRS)

Interventions

near-infrared spectroscopy (NIRS)OTHER

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

healthy patientsother testicular pathologytesticular torsion

Eligibility Criteria

AgeUp to 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsNIRS measurement on testicules
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Spermatic Cord TorsionDisease

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 15, 2023

Study Start

June 24, 2020

Primary Completion

June 24, 2022

Study Completion

September 12, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)