Effect and Safety of Smart Bra (PUMCH)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Effects of the Elements

Intervention / Treatment
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* Device: smart bra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are going to receive breast ultrasound and molybdenum target in breast surgery clinic; Female patients (18-80 years old); Signed written informed consent approved by the relevant institutional review board (IRB) or independent ethics committee (IEC) Exclusion Criteria: The subjects were pregnant or lactating; Patients with nipple discharge; Known allergy to bra materials; The patients who had received breast surgery or breast puncture within half a year; Patients with skin diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The patients who were going to receive double breast ultrasound and molybdenum target in the breast surgery clinic and ward were enrolled into the group (disease-free: benign: malignant = 1:1:1). The patients were put on the device for about 3 minutes, and the breast was photographed at 5 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: smart bra<br>The patients who were going to take breast ultrasound in the breast surgery clinic were enrolled into the group. The patients were put on the device for about 3 minutes, and the breast was photographed at 5 sites. After that, the artificial intelligence learning was carried out on the photos of the training stage. For the photos of the verification stage, the algorithm obtained by the training stage was compared with the existing artificial intelligence algorithms of ultrasound and molybdenum target. | Device: smart bra<br>* This is a patented infrared breast examination bra<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Using ultrasound and / or pathological results as the gold standard, the positive rates of breast diseases (benign breast diseases and malignant breast diseases) detected by smart bra are recorded. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity | Using ultrasound and / or pathological results as the gold standard, the probability of no breast disease (benign breast disease, malignant breast disease) are recorded | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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effectiveness, safety, smart bra