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Effect and Safety of Smart Bra (PUMCH)

NCT ID: NCT04761211

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Effects of the Elements

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The patients who were going to receive double breast ultrasound and molybdenum target in the breast surgery clinic and ward were enrolled into the group (disease-free: benign: malignant = 1:1:1). 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 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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

smart bra

Intervention Type DEVICE

This is a patented infrared breast examination bra

Interventions

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smart bra

This is a patented infrared breast examination bra

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xuefei Wang

Role: STUDY_CHAIR

PUMCH

Locations

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Breast Surgery Department of PUMCH

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Wang X, Chou K, Zhang G, Zuo Z, Zhang T, Zhou Y, Mao F, Lin Y, Shen S, Zhang X, Wang X, Zhong Y, Qin X, Guo H, Wang X, Xiao Y, Yi Q, Yan C, Liu J, Li D, Liu W, Liu M, Ma X, Tao J, Sun Q, Zhai J, Huang L. Breast cancer pre-clinical screening using infrared thermography and artificial intelligence: a prospective, multicentre, diagnostic accuracy cohort study. Int J Surg. 2023 Oct 1;109(10):3021-3031. doi: 10.1097/JS9.0000000000000594.

Reference Type DERIVED
PMID: 37678284 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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PUMCH-ESSB

Identifier Type: -

Identifier Source: org_study_id