NCT04761211

Effect and Safety of Smart Bra (PUMCH)

Effect and Safety of Smart Bra of Peking Union Medical College & Hospital

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,141 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, prospective clinical study was conducted to evaluate the safety and effectiveness of Xiehe smart bra for breast disease screening in outpatients with breast surgery. According to the patients' wishes and written informed consent, they were randomly assigned to the study group. A total of 2000 patients were expected to be enrolled. The training group: validation group = 1:1.

Detailed description

This study is a randomized, open, multicenter clinical study. It will be conducted in Peking Union Medical College Hospital, Shanxi Provincial People's Hospital, Beijing Third Hospital, Zhalantun ZhongMeng hospital, Chongqing Medical University affiliated university town hospital, Shenzhen People's Hospital and other national hospitals. A total of 2000 subjects are expected to participate. The patients in the group wore the device for about 3 minutes, and took photos of 5 breast sites. After that, the artificial intelligence learning was carried out on the photos of the training group. For the photos of the verification group, the algorithm obtained by the training group was compared with the existing artificial intelligence algorithms of ultrasound and molybdenum target. During the follow-up, the safety of the product was evaluated. According to the basic principles of safety and performance of who international general GHTF (sg1-n020r5) medical devices.

Conditions

• Effects of the Elements

Interventions

Type	Name	Description
DEVICE	smart bra	This is a patented infrared breast examination bra

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-07-01
• Completion: 2021-10-01
• First posted: 2021-02-18
• Last updated: 2021-10-21

Locations

1 site across 1 country: China