NCT07545278 Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?
| NCT ID | NCT07545278 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sheffield Children's NHS Foundation Trust |
| Condition | Torsion Testis |
| Study Type | INTERVENTIONAL |
| Enrollment | 107 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 107 participants in total. It began in 2025-04-30 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07545278 clinical trial?
This trial is open to male participants only, up to 19 Years, studying Torsion Testis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07545278 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07545278 currently recruiting?
Yes, NCT07545278 is actively recruiting participants. Contact the research team at c.macdonald.prof@gmail.com for enrollment information.
Where is the NCT07545278 trial being conducted?
This trial is being conducted at Sheffield, United Kingdom.
Who is sponsoring the NCT07545278 clinical trial?
NCT07545278 is sponsored by Sheffield Children's NHS Foundation Trust. The trial plans to enroll 107 participants.