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A parallel blinded comparative study of artificial intelligence breast ultrasound system (AIBUS) and artificial ultrasound in primary female breast disease screening

A parallel blinded comparative study of artificial intelligence breast ultrasound system (AIBUS) and artificial ultrasound in primary female breast disease screening

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049046
Enrollment
Unknown
Registered
2021-07-20
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Breast Cancer

Interventions

Gold Standard:Pathological examination results and final follow-up disease outcome
Index test:Hand-held&#32
ultrasound?Artificial&#32
Intelligence&#32
Breast&#32
Ultrasound&#32
System(AIBUS)

Sponsors

West China School of Public Health and West China Fourth Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 35 to 69 years old; 2. Women who voluntarily undergo both traditional manual breast ultrasound and AIBUS examinations.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breastfeeding; 2. Women with malignant tumors; 3. Women with history of mental illness; 4. Women with history of mastectomy and implantation.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Flase Positive Rate;Flase Negative Rate;Kappa value;—

Countries

China

Contacts

Public ContactLi Jiayuan

West China School of Public Health and West China Fourth Hospital, Sichuan University

lijiayuan@scu.edu.cn+86 15908192011

Outcome results

None listed

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