Exploratory clinical trial using a ring type breast ultrasonic imaging device (ring echo)
- Conditions
- Breast diseases
- Registration Number
- JPRN-jRCTs032190078
- Lead Sponsor
- Akashi Sadako
- Brief Summary
This study succeeded in examining 191 patients and obtaining breast ultrasonic images to exploratory evaluate the safety and efficacy of the device for breast cancer screening. Regarding safety, no adverse events was found and 93% of the respondents were comfortable with the breast cancer screening with it. Regarding efficacy, we successfully described the internal structure of the breasts. In the future, we will collaborate with clinicians to create image interpretation guidelines for ring echo images.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 191
1) Breast cancer suspect patients or breast cancer patients before any treatment
2) Female, age 20 or older at the time of consent acquisition
3) Agreed in a written informed consent
1)Currently breastfeeding
2)Bilateral or unilateral mastectomy
3)Unable to get on and off the ring echo device by oneself or unable to lay prone on the ring echo device for 30 minutes
4)Pregnant or may be pregnant
5) 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 Coincidence of finding lesions to be examined
- Secondary Outcome Measures
Name Time Method 1)Coincidence of category <br>2)Diagnostic Ability of ring echo device