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Research on the Application of AI-Assisted Electromagnetic Navigation Multimodal Imaging Fusion Ultrasound System in Ultrasound-Guided Prostate Targeted Biopsy

Research on the Application of AI-Assisted Electromagnetic Navigation Multimodal Imaging Fusion Ultrasound System in Ultrasound-Guided Prostate Targeted Biopsy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094444
Enrollment
Unknown
Registered
2024-12-23
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

Gold Standard:pathology
Index test:1.Primary observation indicator: Biopsy positive rate 2.Secondary observation indicators: Procedure time for each group (local anesthesia time + prostate biopsy time),Targeted biopsy positi

Sponsors

Zhejiang Provincial Hospital of Traditional Chinese Medicine (First Affiliated Hospital of Zhejiang Chinese Medical University)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1.PSA > 10 ng/ml; 2.PSA 4-10 ng/ml with abnormal f/t PSA or PSAD; 3.Suspicious prostate nodule detected on digital rectal examination; 4.Suspicious prostate lesions identified on TRUS, MRI, or PSMA PET/CT; 5.Patients who agree to participate in the study and provide informed consent.

Exclusion criteria

Exclusion criteria: 1.In the acute infection or febrile phase; 2.Dysfunction of vital organs such as the heart, lungs, or brain; 3.Use of anticoagulants, antiplatelet drugs, or a tendency to bleed; 4.Poorly controlled or unstable comorbid conditions such as hypertension or diabetes; 5.Severe internal or external hemorrhoids, perianal or rectal lesions; 6.Severe immunosuppressive state; 7.Severe psychological disorders or patients who are uncooperative with the procedure; 8.Patients unable to comply with the study protocol or follow-up requirements.

Design outcomes

Primary

MeasureTime frame
Biopsy positive rate;

Secondary

MeasureTime frame
Targeted biopsy positive rate;Procedure time for each group;Effective biopsy rate;Tissue sample length;Intraoperative blood loss;Incidence of complications;Patient pain score;

Countries

China

Contacts

Public ContactJiasheng Yan

Zhejiang Provincial Hospital of Traditional Chinese Medicine (First Affiliated Hospital of Zhejiang Chinese Medical University)

yanjiashengurology@163.com+86 151 6825 6544

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026