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Not yet recruitingNCT07301086Updated Dec 31, 2025

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

An observational study in Testicular Appendix Torsion, Testicular Torsion and Epididymitis, sponsored by Ying Jiang. Not yet recruiting at 1 site in China. Open to male participants aged 1 Minute to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by Ying Jiang · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,000
Ages
1 Minute to 18 Years
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Testicular Appendix Torsion
  • Testicular Torsion
  • Epididymitis

Keywords

  • Testicular Appendix Torsion
  • Deep Learning
  • Ultrasonic Diagnosis
03

In context

Lead sponsor

This is the only study on the registry with Ying Jiang as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 18 Years
Sexes eligible
Male
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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])
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Accuracy of deep-learning model verify four conditions:testicular appendage torsion;testicular torsion;epididymitis and normal condition

    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

Secondary outcomes

  1. Number of Participants with Acute Scrotal Pain

    Time frame: From enrollment begin to the end is expected to be 5 months

  2. 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

  3. 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

07

Study locations

1 site
  • Children's Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310000, China
    • Ying Jiang, Master Degree · ContactJiang_ying@zju.edu.cn · 86-19883203100
    • Jingjing Ye, PHD Degree · Contact86-13868174280
    • Ying Jiang, Master Degree · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — the patient's ultrasound images and baseline data

Supporting information: Study protocol

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

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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07301086
Lead sponsor
Ying Jiang
Responsible party
Ying Jiang (resident physician, The Children's Hospital of Zhejiang University School of Medicine) — Sponsor-investigator
First posted
Dec 24, 2025
Start date
Jan 2026 (estimated)
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Dec 31, 2025

Study contacts

Ying Jiang, Master Degree
Contact
Jiang_ying@zju.edu.cn
86-19883203100
Juntao Jiang, Master Degree
Contact
juntaojiang@zju.edu.cn
86-13968107281
Jingjing Ye, Phd Degree
study director · The Children's Hospital of Zhejiang University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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