RecruitingPhase 4NCT07545278

Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?

Assessment of Diagnostic Accuracy of Indocyanine Green Fluorescence Imaging in Children and Young People With Testicular Pain Requiring Surgical Exploration Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?


Sponsor

Sheffield Children's NHS Foundation Trust

Enrollment

107 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Testicular torsion is a time critical condition for children and young people (CYP). It is difficult to diagnose without an operation. Missing it means the child will lose a testicle. There are no good diagnostic tests, only tests that delay the child's journey to theatre, which puts them at further risk of losing the testicle. Most boys with a painful testicle get a surgical exploration to see if it is torsion and to twist and fix it. Up to 85% of children having surgery will not have torsion. They will have something they didn't need surgery for. We want to see whether a new, low risk, fast investigation could be used to diagnose the problem, meaning no torsions are missed and less children have unnecessary surgery.


Eligibility

Sex: MALEMax Age: 19 Years

Inclusion Criteria1

  • All children presenting with testicular pain, being taken to theatre for scrotal exploration at Sheffield Children's NHS Foundation Trust. Aged 0-19 years of age.

Exclusion Criteria3

  • Children with any allergy to contrast medium or iodine will be excluded.
  • Any family or young person > age 13 years refusing consent.
  • Children without a GP will not be exempt from recruitment. No information is required from community care.

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Interventions

DIAGNOSTIC_TESTIndocyanine green fluorescence injection and near infra red spectroscopy image capture

As above


Locations(1)

Sheffield Children's Hospital

Sheffield, South Yorkshire, United Kingdom

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NCT07545278


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