Status:
COMPLETED
Effect and Safety of Smart Bra (PUMCH)
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Effects of the Elements
Eligibility:
FEMALE
18-80 years
Phase:
NA
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 t...
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 Zhon...
Eligibility Criteria
Inclusion
- Patients who are going to receive breast ultrasound and molybdenum target in breast surgery clinic;
- Female patients (18-80 years old);
- Signed written informed consent approved by the relevant institutional review board (IRB) or independent ethics committee (IEC)
Exclusion
- The subjects were pregnant or lactating;
- Patients with nipple discharge;
- Known allergy to bra materials;
- The patients who had received breast surgery or breast puncture within half a year;
- Patients with skin diseases.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
2141 Patients enrolled
Trial Details
Trial ID
NCT04761211
Start Date
August 1 2020
End Date
October 1 2021
Last Update
October 21 2021
Active Locations (1)
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1
Breast Surgery Department of PUMCH
Beijing, Beijing Municipality, China, 100032