Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?

NCT07545278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-07-31

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07545278 on ClinicalTrials.gov