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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04761211
Other study ID # PUMCH-ESSB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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