Safety and Efficacy Clinical Study of Hand-held Prostate Puncture Robot

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500096962

Enrollment

Unknown

Registered

2025-02-10

Start date

2024-05-15

Completion date

Unknown

Last updated

2025-02-17

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 with free hand

Index test:Prostate biopsy cancer-positive rate

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) PSA>10ng/ml; (2) PSA4-10/ml, but Fpsa/PSA<0.16; (3) DRE found abnormalities; (4) MRI/US found suspicious lesions.

Exclusion criteria

Exclusion criteria: (1) Fever, body temperature > 37.5 degrees Celsius (2) Abnormal coagulation function, risk of bleeding; (3) Cardiopulmonary or other serious organ diseases that cannot tolerate anesthesia.

Design outcomes

Primary

Measure	Time frame
Positive rate of biopsy;	—

Secondary

Measure	Time frame
Number of puncture needles;	—

Countries

China

Contacts

Public ContactHuageng Liang

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

leonard19800318@hust.edu.cn+86 186 2707 0973

Outcome results

None listed

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