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

NCT ID: NCT07301086

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-05-31

Brief Summary

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Ultrasound data were retrospectively 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, YOLOv11 was adopted as the detection network, which was integrated with the convolutional attention mechanism (Spatial Convolutional Block Attention Module, namely Spatial CBAM) and the self-attention mechanism (e.g., Attention Convolution Mixer, ACMix). The 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 the dataset from the sub-center.Meanwhile, four physicians were assigned to interpret the ultrasound data from the 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 dataset, and comparing the proportion of surgeries predicted by AI with the actual proportion of surgeries, the efficacy of the model was verified.

Detailed Description

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Ultrasound data were retrospectively 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, YOLOv11 was adopted as the detection network, which was integrated with the convolutional attention mechanism (Spatial Convolutional Block Attention Module, namely Spatial CBAM) and the self-attention mechanism (e.g., Attention Convolution Mixer, ACMix). The 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 the dataset from the sub-center.Meanwhile, four physicians were assigned to interpret the ultrasound data from the 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 dataset, and comparing the proportion of surgeries predicted by AI with the actual proportion of surgeries, the efficacy of the model was verified.

Conditions

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Testicular Appendix Torsion Testicular Torsion Epididymitis

Keywords

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Testicular Appendix Torsion Deep Learning Ultrasonic Diagnosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Testicular Appendix Torsion Group

Patients diagnosed with testicular appendage torsion

No interventions assigned to this group

Testicular Torsion Group

Patients diagnosed with testicular torsion

No interventions assigned to this group

Epididymitis Group

Patients diagnosed with epididymitis

No interventions assigned to this group

Normal Group

Patients with no testicular appendage torsion,testicular torsion,epididymitis,and the scrotum is normal

No interventions assigned to this group

Eligibility Criteria

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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 \[TAT\])
Minimum Eligible Age

1 Minute

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ying Jiang

OTHER

Sponsor Role lead

Responsible Party

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Ying Jiang

resident physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jingjing Ye, Phd Degree

Role: STUDY_DIRECTOR

Zhejiang University School of Medicine Children's Hospital

Locations

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Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Ying Jiang, Master Degree

Role: CONTACT

Phone: 86-19883203100

Email: [email protected]

Juntao Jiang, Master Degree

Role: CONTACT

Phone: 86-13968107281

Email: [email protected]

Facility Contacts

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Ying Jiang, Master Degree

Role: primary

Jingjing Ye, PHD Degree

Role: backup

Other Identifiers

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CHZhejiangjiangying

Identifier Type: -

Identifier Source: org_study_id