Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?
NCT07545278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-07-31
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.
Conditions
- Torsion Testis
- Scrotum Disease
Interventions
- DIAGNOSTIC_TEST
-
Indocyanine green fluorescence injection and near infra red spectroscopy image capture
As above
Sponsors & Collaborators
-
Sheffield Children's NHS Foundation Trust
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Max Age
- 19 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-04-30
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
Countries
- United Kingdom
Study Locations
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