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RECRUITING
NCT07545278
PHASE4

Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?

Sponsor: Sheffield Children's NHS Foundation Trust

View on ClinicalTrials.gov

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.

Official title: 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?

Key Details

Gender

MALE

Age Range

Any - 19 Years

Study Type

INTERVENTIONAL

Enrollment

107

Start Date

2025-04-30

Completion Date

2026-06-30

Last Updated

2026-04-22

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Indocyanine green fluorescence injection and near infra red spectroscopy image capture

As above

Locations (1)

Sheffield Children's Hospital

Sheffield, South Yorkshire, United Kingdom