Effect and Safety of Smart Bra (PUMCH)

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

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.

Study Overview

• Status: Completed
• Conditions: Effects of the Elements
• Intervention / Treatment: Device: smart bra

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.

• Study Type: Interventional
• Enrollment (Actual): 2141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Breast Surgery Department of PUMCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: smart bra; 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; This is a patented infrared breast examination bra

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Xuefei Wang, PUMCH

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: safety; effectiveness; smart bra
• Other Study ID Numbers: PUMCH-ESSB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will decide during this trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No