NCT07133243

Brief Summary

The goal of this observational study is to assess the diagnostic concordance between testicular Doppler ultrasound of the spermatic cord vessels performed by an emergency physician and the diagnosis of testicular torsion made by the urologist during an exploration in the operating room (Gold standard) in men patients between 16 to 70 years old with suspicion of testicular torsion. Participants will receive ultrasound performed by emergency physician during their visit to the emergency department. Results of this exam will be compare to gold standard. If the results are consistent, the investigators will have demonstrated the value of integrating ultrasound by the emergency physician into the management of testicular torsion.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Nov 2025

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 Progress47%
Nov 2025Nov 2026

First Submitted

Initial submission to the registry

August 5, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 3, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 5, 2025

Last Update Submit

August 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patient with diagnostic of testicular torsion

    Concordance between testicular ultrasound and chirurgical diagnostic of testicular torsion

    At enrollement

Secondary Outcomes (4)

  • Identify predictive factors for diasgnosis of testicular torsion

    At enrollement

  • Epidemiological factors of testicular pain

    At enrollement

  • Doppler result concordance between emergency physician and radiologist

    From enrollement to 48 hours

  • Characterised patients who benefit ultrasound from a radiologist according to final diagnostic

    From enrollement to 48 hours

Study Arms (1)

single arm

Other: testicular ultrasound

Interventions

each patient will receive an testicular ultrasound to confirm diagnostic of testicular torsion

single arm

Eligibility Criteria

Age16 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population will be selected from male (from 16 to 70) presenting testicular pain in emergency unit of Roubaix's hospital

You may qualify if:

  • Male patients
  • Minimum age of 16 years and maximum age of 70 years
  • Presenting with unilateral testicular pain lasting less than 72 hours
  • Admitted to the Roubaix Hospital Emergency
  • Presence of an emergency physician trained in performing testicular ultrasound during the transition to the Emergency unit
  • Patient who did not object to participating in the study

You may not qualify if:

  • Recent history (less than one month) of ipsilateral testicular torsion, testicular trauma, or testicular surgery
  • Patient with a history of sex reassignment, currently undergoing sex reassignment, or taking sex reassignment hormones
  • Innate or acquired absence of one of the two testicles within the scrotum
  • Patient who has already been included once in the TESTI study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH de Roubaix

Roubaix, 59100, France

Location

MeSH Terms

Conditions

Spermatic Cord Torsion

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Dr Perrine LIBERT, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 20, 2025

Study Start

November 3, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations