NCT07324590

Brief Summary

Acute scrotal pain due to testicular torsion is a rare but urgent urological condition that requires immediate surgery to prevent permanent damage or loss of the testicle. Early detection is crucial to minimize delays from the onset of pain to operative treatment. The diagnosis of torsion involves a combination of physical examination and imaging studies, such as Doppler ultrasound (DU). However, DU requires an experienced radiologist and may cause unnecessary time delays. Thermal imaging is a noninvasive technique that can detect skin surface temperature variations using a highly sensitive infrared camera. Although there are some promising animal studies using thermal imaging for the diagnosis of testicular ischemia, number of studies in humans is very limited. According to a small pilot study in 2024, thermal imaging is a fast, feasible and noninvasive diagnostic tool that seems to have considerable potential in the evaluation of patients with acute testicular pain, especially those with symptoms of testicular torsion. However, further research with a larger sample size is needed. In this multicenter study, the investigators aim is to determine the role of thermal imaging in the diagnosis of acute testicular pain. Males with acute testicular pain entering emergency are included. After informed consent thermal image of testicles will be taken before any additional investigations such as laboratory tests and DU. Participants are treated as usual and testicular temperatures will be correlated with final diagnosis after approximately 6-month study period is over.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

November 21, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

November 21, 2025

Last Update Submit

December 23, 2025

Conditions

Keywords

Testicular torsionepididymitestesticular appendages torsionTesticular pain

Outcome Measures

Primary Outcomes (1)

  • To determine role of thermal imaging in the diagnoses of acute testicular pain. To evaluate the effect of funicular ligation on testicular temperature (substudy 1).

    Temperatures of testicles * Comparison of temperatures (temperature diffrence) in Celsius of symptomatic and asymptomatic testicles * Temperatures of testicle in Celsius before and 5, 10 and 15 minutes after ligation of funicle (substudy 1)

    Thermal picture is taken once at baseline. In substudy 1, thermal pictures of testicle will be taken at 0, 5, 10 and 15 minutes

Study Arms (1)

Patients with acute testicular pain

EXPERIMENTAL
Device: Thermidas thermal camera

Interventions

This kind of study has not been perfomed before

Patients with acute testicular pain

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males, who come to emergency department due to acute testicular pain and sign informed consent.
  • Sub-study 1: Adult males, who are having funicular orchiectomy due to testicular cancer and sign informed consent.

You may not qualify if:

  • Previous surgery or other operative procedure such as puncture in scrotal area within 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanneksenrinne 7

Seinäjoki, 60220, Finland

Location

Related Publications (1)

  • Brooks JP, Brooks JM, Seals T. Smartphone Thermal Imaging in the Detection of Testicular Ischemia. Urology. 2021 Nov;157:233-238. doi: 10.1016/j.urology.2021.02.031. Epub 2021 Mar 6.

    PMID: 33689763BACKGROUND

MeSH Terms

Conditions

Testicular DiseasesSpermatic Cord Torsion

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Mika P Raitanen, M.D., Ph.D, associate prof

    Seinöjoki Central Hospital

    STUDY CHAIR

Central Study Contacts

Mika P Raitanen, M.D, Ph.D, associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, chief clinician

Study Record Dates

First Submitted

November 21, 2025

First Posted

January 7, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 7, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR

Locations