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Data collection for a breast ultrasonic imaging device

Data collection for a breast ultrasonic imaging device

200

This study was conducted on women over the age of 20. Two hundred patients were enrolled.One withdrew consent and ring echo screening was performed on 199 patients. 198 patient's data was analyzed. One patient was excluded as an overflow of hot water from the inspection tank meant the inspection could not be completed. The 198 patients had an average age of 49.7, an average height of 157.9 cm, and an average weight of 56.3 kg.

March 23, 2021: First case registration June 5, 2021: Final case registered September 30, 2021: Follow-up completed

No adverse events occurred. There were two equipment failures. One was physical damage,and the other was an error in recovery work from detected anomalies. Neither led to adverse events.

Primary endpoint: In the ring echo images, the incidence of images with artifacts due to lack of penetration inside the breast was 10.0% (95% CI: 9.6-10.4%), and the degree of impact (ratio of artifact area to breast area) was 0.25%. Secondary endpoint: GCNR (The Generalized Contrast-to-Noise Ratio) of the tumors visualized by the ring echo images and diagnosed as malignant masses and benign masses in normal medical care were 0.66 (95% CI: 0.61-0.71) and 0.65 (95% CI: 0.59-0.71).

We obtained registration of 200 women over 20 years old, performed ring echo examinations of 198, and succeeded in collecting breast images.Insufficient penetration was confirmed in 10% of the acquired images, but the degree of influence was as low as 0.25%. Regarding safety, no adverse events were found.

April. 06, 2022

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs032200416

Furusawa Hidemi

Breast surgical oncology clinic, Kawaguchi kogyo general hospital

F1-2 BRANZ Kawaguchi-Motogo 1-18-21 Aoki, Kawaguchi, Saitama

hidemi.furusawa@kogyohsp.gr.jp

Furusawa Hidemi

Breast surgical oncology clinic, Kawaguchi kogyo general hospital

F1-2 BRANZ Kawaguchi-Motogo 1-18-21 Aoki, Kawaguchi, Saitama

+81-48-229-0707

hidemi.furusawa@kogyohsp.gr.jp

Complete

Mar. 12, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

1)Female, Age 20 or older at the time of consent acquisition
2)A person who has obtained an informed consent with sufficient explanation to participate in this study
3)Those who are planning to have breast surgery and can have a ring echo examination before breast surgery

1) Unable to get on and off the device by oneself or unable to lay prone on the device for 30 minutes
2)Pregnant women or women who are capable of pregnancy
3)Patients who had heart pacemaker or implantable cardioverter defibrillator
4)Judged by a doctor to be in a condition inappropriate for the participation in the study

Female

Breast diseases

Breast imaging using a device

Evaluation of image

1)Evaluation of image
2)Patient safety and comfort

+81-3-3784-8129

Mar. 04, 2021

none