臨床研究等提出・公開システム

Exploratory clinical trial using a breast ultrasonic imaging device

Exploratory clinical trial using a breast ultrasonic imaging device

43

This study was conducted on women or men with breast lesions over the age of 20. We obtained registration of 43, but the study was discontinued due to a change in the business plan triggered by deteriorating business conditions of the medical device provider, and data was not fixed, so statistical analysis was not performed.

September 13, 2019: First case registration November 30, 2022: Final case registered January 25, 2023: Follow-up completed

One adverse event occurred. The degree was mild, and there was a causal relationship with this study, and it was an abrasion due to the opening shape of measurement area. No equipment failure occurred.

Because the study was discontinued due to a change in the business plan triggered by deteriorating business conditions of the medical device provider, data was not fixed, and statistical analysis was not performed.

This study was conducted on women or men with breast lesions over the age of 20. We obtained registration of 43 patients and succeeded in collecting breast images of all.One of the 43 patients was discontinued due to a violation of the inclusion criteria. Regarding safety, there was one case of adverse event. After that, the study was discontinued due to a change in the business plan triggered by deteriorating business conditions of the medical device provider, and statistical analysis were not performed.

April. 01, 2025

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs032190090

Nishioka Kotoe

The University of Tokyo Hospital

7-3-1, Hongo, Bunkyo-ku, Tokyo

NISHIOKAK-SUR@h.u-tokyo.ac.jp

Nishioka Kotoe

The University of Tokyo Hospital

7-3-1, Hongo, Bunkyo-ku, Tokyo

+81-3-3815-5411

NISHIOKAK-SUR@h.u-tokyo.ac.jp

Complete

Sept. 03, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

1) Male with their breast disease and female
2) Age 20 or older at the time of consent acquisition
3) A person who has obtained an informed consent with sufficient explanation to participate in this study

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

Both

Breast diseases

Breast imaging using a device

Imaging area

1)Evaluation of image
2)Feasibility study

+81-3-5841-0818

Aug. 30, 2019

none