Data collection for a breast ultrasonic imaging device

Not Applicable

• Conditions: Breast diseases

• Registration Number: JPRN-jRCTs032200416
• Lead Sponsor: Furusawa Hidemi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-12
• Study Completion: 2021-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of image

Secondary Outcome Measures

Name	Time	Method
1)Evaluation of image<br>2)Patient safety and comfort