Effect and Safety of Smart Bra (PUMCH)
NCT04761211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2141
Last updated 2021-10-21
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.
Conditions
- Effects of the Elements
Interventions
- DEVICE
-
smart bra
This is a patented infrared breast examination bra
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Xuefei Wang · PUMCH
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-08-01
- Primary Completion
- 2021-07-01
- Completion
- 2021-10-01
Countries
- China
Study Locations
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