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New dye test could save testicles and spare thousands of boys from needless surgery

NCT ID NCT07545278

Diagnosis Sponsor: Sheffield Children's NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tests a new imaging method using a safe dye called indocyanine green (ICG) to quickly tell if a child's testicular pain is due to torsion (twisted testicle) or something else. About 85% of children who have surgery for testicular pain don't actually have torsion. The goal is to see if ICG imaging can accurately diagnose torsion during surgery, so no torsions are missed and fewer children have unnecessary operations. The study will include 107 children and young people aged 0-19.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

18 people

The number who actually took part.

Started

Apr 2025

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 19 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

scrotal disorder spermatic cord torsion

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Scrotum disease Torsion testis

Contacts and locations

Locations

  • Sheffield Children's Hospital

    Sheffield, South Yorkshire, S10 2TH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.