A Study on the Effectiveness of Diagnosis Support Using AI in a Ring Array Ultrasonic Imaging Device for the Breast

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032210683

Enrollment

800

Registered

2022-03-22

Start date

2022-03-30

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Breast diseases

Interventions

Breast imaging using a device

D016217

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1)Female, Age 20 or older at the time of consent acquisition 2) Patients who provide consent in written form with sufficient understanding of the study after appropriate informed consent

Exclusion criteria

Exclusion criteria: 1) Those unable to get on and off the device without assistance or unable to lie prone on the device 2) Those who weigh 135 kg or more 3) Those with an open wound in the breast 4) Those who have a pacemaker or implantable cardioverter defibrillator 5) Those equipped with devices that require an external oxygen or power supply, such as an artificial heart or infusion pump 6) Those that the doctor deems that do not meet the condition requirements of the study

Design outcomes

Primary

Measure	Time frame
Detectability evaluation of AI-aided detection	—

Secondary

Measure	Time frame
1) Evaluation of image 2) Data collection 3) Patient comfort	—

Contacts

Public ContactKazuyo Yagishita

St. Luke's International University St. Luke's International Hospital

kazuyoyg@luke.ac.jp+81-3-3541-5151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026