Effect and Safety of Smart Bra (PUMCH)

Effects of the Elements Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761211
• Other study ID #: PUMCH-ESSB
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2141
• Est. completion date: October 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effects of the Elements

Intervention

Device:
• smart bra
This is a patented infrared breast examination bra

Locations

Country	Name	City	State
China	Breast Surgery Department of PUMCH	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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