Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
AgeUp to 19
SponsorSheffield Children's NHS Foundation Trust
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Indocyanine green fluorescence injection and near infra red spectroscopy image capture
Treatment groups
107 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov