Clinical trial NCT04761211: Effect and Safety of Smart Bra (PUMCH)
Official title: Effect and Safety of Smart Bra of Peking Union Medical College & Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of the Elements
Keywords: effectiveness
safety
smart bra
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 2141
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who are going to receive breast ultrasound and molybdenum target in breast surgery clinic;
2. Female patients (18-80 years old);
3. Signed written informed consent approved by the relevant institutional review board (IRB) or independent ethics committee (IEC)

Exclusion Criteria:

1. The subjects were pregnant or lactating;
2. Patients with nipple discharge;
3. Known allergy to bra materials;
4. The patients who had received breast surgery or breast puncture within half a year;
5. Patients with skin diseases.

Primary outcomes:
measure: Sensitivity
timeFrame: baseline
Secondary outcomes:
measure: Specificity
timeFrame: baseline
Other outcomes:
measure: Number of adverse events assessed by CTCAE v4.0
timeFrame: baseline; 3months
Locations:
city: Beijing
country: China
facility: Breast Surgery Department of PUMCH
state: Beijing
Study officials:
affiliation: PUMCH
name: Xuefei Wang
role: STUDY_CHAIR
References: