Effects of the ElementsNCT04761211
Effect and Safety of Smart Bra (PUMCH)
A study testing smart bra in people with Effects of the Elements, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of the Elements
- What is being tested?
- smart bra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,141 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Breast Surgery Department of PUMCH
Beijing, Beijing Municipality, 100032
About this study
Official title: Effect and Safety of Smart Bra of Peking Union Medical College & Hospital
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.
Read the 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 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
- Effects of the Elements
- Being tested
- smart bra
- Keywords
- effectiveness, safety, smart bra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart braDevice
This is a patented infrared breast examination bra
| Study group | Role | What they receive |
|---|---|---|
| smart bra | Experimental | 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. Receives: Device: smart bra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (1)
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Aug 2020
- Primary completion1 Jul 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effects of the ElementsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xuefei Wang, Study chair, PUMCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761211
- Sponsor's protocol ID
- PUMCH-ESSB
- Status last verified
- Oct 2021
- First submitted
- 2 Sep 2020
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will decide during this trial.
Publications
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.
PubMed 37678284
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Smart Bra of Peking Union Medical College & Hospital
- ClinicalTrials.gov ID
- NCT04761211
- Acronym / sponsor ID
- PUMCH-ESSB
- Conditions
- Effects of the Elements
- Keywords
- effectiveness, safety, smart bra
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,141 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| smart bra | Experimental | Device: smart braThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smart braThis is a patented infrared breast examination bra | Device | smart bra |
Primary outcome
Sensitivity
Time frame: baseline
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.
1 secondary outcome
Specificity
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Derived from this study: PubMed 37678284Wang 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.
- Individual participant dataSharing planned: No. We will decide during this trial.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuefei Wang study chair
PUMCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smart bra in people with Effects of the Elements, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04761211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.