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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| smart bra | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smart bra | Device | This is a patented infrared breast examination bra |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events assessed by CTCAE v4.0 | Number of participants with smart-bra related adverse events as assessed by CTCAE v4.0 | baseline; 3months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuefei Wang | PUMCH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Surgery Department of PUMCH | Beijing | Beijing Municipality | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37678284 | Derived | Wang X, Chou K, Zhang G, Zuo Z, Zhang T, Zhou Y, Mao F, Lin Y, Shen S, Zhang X, Wang X, Zhong Y, Qin X, Guo H, Wang X, Xiao Y, Yi Q, Yan C, Liu J, Li D, Liu W, Liu M, Ma X, Tao J, Sun Q, Zhai J, Huang L. Breast cancer pre-clinical screening using infrared thermography and artificial intelligence: a prospective, multicentre, diagnostic accuracy cohort study. Int J Surg. 2023 Oct 1;109(10):3021-3031. doi: 10.1097/JS9.0000000000000594. |
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We will decide during this trial.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 9, 2021 | Feb 10, 2021 | Prot_SAP_ICF_000.pdf |
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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.
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