Deep Learning-Assisted Ultrasonic Diagnosis and Localization of Testicular Appendix Torsion

December 24, 2025 updated by: Ying Jiang

Deep Learning-Assisted Ultrasonic Diagnosis and Localization of Testicular Appendix Torsion: A Multicenter Retrospective Validation Study

Ultrasound data were both retrospectively and prospectively collected from the primary center and six other sub-centers. Combined with clinical diagnostic outcomes, the data labeling was completed by physicians with extensive clinical experience. In this study, ConvNeXtV2 was used as the classification network and YOLOv12 was adopted as the detection network.The retrospective dataset from the primary center was split into training, validation, and test subsets, on which the model was trained, validated, and tested respectively; additional validation was conducted on both retrospective and prospective datasets from the primary center and sub-centers.Meanwhile, four physicians were assigned to interpret the ultrasound data from the retrospective and prospective datasets from the primary center and sub-centers using two diagnostic methods-independent diagnosis and artificial intelligence (AI)-assisted diagnosis-and the diagnostic accuracy of these two approaches was further compared.By collecting and learning the treatment methods of patients in the primary center training set, predicting the treatment methods of patients in the sub-center datasets, and comparing the proportion of surgeries predicted by AI with the actual proportion of surgeries, the efficacy of the model was verified.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Ultrasound data were both retrospectively and prospectively collected from the primary center and six other sub-centers. Combined with clinical diagnostic outcomes, the data labeling was completed by physicians with extensive clinical experience. In this study, ConvNeXtV2 was used as the classification network and YOLOv12 was adopted as the detection network.The retrospective dataset from the primary center was split into training, validation, and test subsets, on which the model was trained, validated, and tested respectively; additional validation was conducted on both retrospective and prospective datasets from the primary center and sub-centers.Meanwhile, four physicians were assigned to interpret the ultrasound data from the retrospective and prospective datasets from the primary center and sub-centers using two diagnostic methods-independent diagnosis and artificial intelligence (AI)-assisted diagnosis-and the diagnostic accuracy of these two approaches was further compared.By collecting and learning the treatment methods of patients in the primary center training set, predicting the treatment methods of patients in the sub-center datasets, and comparing the proportion of surgeries predicted by AI with the actual proportion of surgeries, the efficacy of the model was verified.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Children's Hospital of Zhejiang University School of Medicine
        • Contact:
        • Contact:
          • Jingjing Ye, PHD Degree
          • Phone Number: 86-13868174280
        • Principal Investigator:
          • Ying Jiang, Master Degree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Age ≤ 18 years old，underwent ultrasound examination due to acute scrotal pain (≤ 24 hours)

Description

Inclusion Criteria:

  1. Age ≤ 18 years old
  2. Underwent ultrasound examination due to acute scrotal pain (≤ 24 hours)
  3. Patients clinically diagnosed with testicular appendage torsion (TAT)

Exclusion Criteria:

  1. Poor ultrasound image quality (failure to identify testicular structures)
  2. Incomplete clinical data (failure to confirm the diagnosis of testicular appendage torsion [TAT])

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Testicular Appendix Torsion Group
Patients diagnosed with testicular appendage torsion
Testicular Torsion Group
Patients diagnosed with testicular torsion
Epididymitis Group
Patients diagnosed with epididymitis
Normal Group
Patients with no testicular appendage torsion,testicular torsion,epididymitis,and the scrotum is normal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy of deep-learning model verify four conditions:testicular appendage torsion;testicular torsion;epididymitis and normal condition
Time Frame: From image input to result generation is expected to be 24 hours
accuracy of deep-learning model verify four conditions:testicular appendage torsion;testicular torsion;epididymitis and normal condition
From image input to result generation is expected to be 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants with Acute Scrotal Pain
Time Frame: From enrollment begin to the end is expected to be 5 months
From enrollment begin to the end is expected to be 5 months
The accuracy rate of clinicians in diagnosing and localizing testicular appendix torsion
Time Frame: From the begin of Clinicians diagnose and locate to the end is expected to be 15 days
From the begin of Clinicians diagnose and locate to the end is expected to be 15 days
The accuracy rate of the Deep learning model in predicting the treatment modality for testicular appendix torsion,conservative treatment or surgery
Time Frame: From the begin of the prediction of treatment for testicular appendix torsion by Deep learning model to the end is expected to be 24 hours
From the begin of the prediction of treatment for testicular appendix torsion by Deep learning model to the end is expected to be 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ying Jiang

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jingjing Ye, Phd Degree, Zhejiang University School of Medicine Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHZhejiangjiangying

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the patient's ultrasound images and baseline data

IPD Sharing Time Frame

The IPD and supporting information will be available at 1st Jan,2027, and for one month

IPD Sharing Access Criteria

Journal editors and reviewers,study protocol,send me email to access it.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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