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The application of TRUS-MRI real-time three dimensional image fusion prostate biopsy system based on novel intracavitary registration device

The application of TRUS-MRI real-time three dimensional image fusion prostate biopsy system based on novel intracavitary registration device

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017443
Enrollment
Unknown
Registered
2018-07-30
Start date
2018-06-26
Completion date
Unknown
Last updated
2018-08-20

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:Prostate biopsy pathology or radical prostatectomy pathology
Index test:TRUS-MRI&#32
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intracavitary&#32
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device

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Men aged less than 80 years old; 2. Suspicious lesion(s) on MRI, not consistent with TRUS; 3. Scheduled for prostate biopsy; 4. Patients who agreed to enter the group and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Accepted any form of treatment of prostate disease before or during the study; 2. Abnormal coagulation examination which is of clinical significance; 3. Abnormal blood routine which is of clinical significance; 4. Abnormal urine routine which is of clinical significance; 5. Abnormal electrocardiogram which is of clinical significance; 6. Unable to stop anticoagulants for five days; 7. May significantly reduce any medical situation or other events to obtain the reliable data, to achieve the purpose of research or to complete the study, and to follow up the opportunity after the trial operation; 8. Research doctors think that it is not appropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
accuracy of biopsy;prostate cancer detection rate;

Secondary

MeasureTime frame
during of biopsy;biopsy complication;Pain degree;

Countries

China

Contacts

Public ContactChen Yaqing

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

joychen1266@hotmail.com+86 021 25077235

Outcome results

None listed

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