Effect and Safety of Smart Bra (PUMCH)

Peking Union Medical College Hospital2,141 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

2,141

Conditions

Effects of the Elements

Interventions

smart braDEVICE

This is a patented infrared breast examination bra

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Breast Surgery Department of PUMCH

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: baseline

Secondary Outcomes

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

Time frame: baseline

Data from ClinicalTrials.gov

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