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Completed
NCT07545278
Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?
Conditions: Torsion Testis, Scrotum Disease
Sex: Male
Ages: N/A – 19 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 18
Sponsor: Sheffield Children's NHS Foundation Trust
Location: Sheffield Children's Hospital Sheffield South Yorkshire
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 Criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07545278). StuddyBuddy aggregates publicly available trial information.