ArrhythmiaNCT05182684
The Collection and Transmission of Electrocardiogram Using a Wearable Device
A study testing Vital Patch(TriBell Lab) in people with Arrhythmia, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Vital Patch(TriBell Lab)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 26 Oct 2021to 21 Jun 2022
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy adult male volunteers who can use an Android smartphone.
- The subjects who voluntarily agree to participate and give written informed consent.
Who cannot join
- The subjects who have hypersensitivity to adhesives, such as medical bandages, or have clinically significant skin lesions.
- The subjects who are judged to be inappropriate for the clinical trials to participate.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Seoul National University Hospital Clinical Trial Center
Seoul, 03080
In-Jin Jang, MD, PhD, +82-2-2072-1910, ijjang@snu.ac.kr
Kyung-Sang Yu, MD, PhD, +82-2-2072-1920, ksyu@snu.ac.kr
- Recruiting
Seoul National University Hospital
Seoul, 03080
Il Song Choi, Doctor, 82-10-9899-3468, jgsaim88@snu.ac.kr
About this study
Official title: A Multi-center Clinical Trial to Explore the Status of Collection and Transmission of Electrocardiogram Using a Wearable Device
A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device
Read the detailed description
The collection and transmission of electrocardiograms to a central data server using a wearable device were evaluated.
- Conditions
- Arrhythmia
- Being tested
- Vital Patch(TriBell Lab)
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital Patch(TriBell Lab)Device
Electrocardiograms were recorded using VP-100 for more than six hours and transmitted to a central data server located in Seoul National University Hospital.
The data on a central server was confirmed and evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Electrocardiograms were measured by VP-100 for more than 6 hours and transmitted to a central server. Receives: Device: Vital Patch(TriBell Lab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of data collected
Compare actual monitored and server collected times
Measured: 6 hours
Secondary outcomes (2)
The comparison of ventricular rate
Compare actual monitored and server collected ventricular rate
Measured: 6 hours
The comparison of abnormal events
Compare patient-reported adverse events with abnormal beats collected by a central server
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start26 Oct 2021
- Primary completion21 Jun 2022 (estimated)
- Study completion21 Jun 2022 (estimated)
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 ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SeungHwan Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182684
- Sponsor's protocol ID
- VP-100-ECG
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huh KY, Jeong SI, Yoo H, Piao M, Ryu H, Kim H, Yoon YR, Seong SJ, Lee S, Kim KH. Lessons from a multicenter clinical trial with an approved wearable electrocardiogram: issues and practical considerations. Transl Clin Pharmacol. 2022 Jun;30(2):87-98. doi: 10.12793/tcp.2022.30.e7. Epub 2022 May 24.
PubMed 35800668
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Trial to Explore the Status of Collection and Transmission of Electrocardiogram Using a Wearable Device
- ClinicalTrials.gov ID
- NCT05182684
- Acronym / sponsor ID
- VP-100-ECG
- Conditions
- Arrhythmia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 21 Jun 2022 (estimated)
- Study completion
- 21 Jun 2022 (estimated)
- First posted
- 10 Jan 2022 (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.
A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device
Detailed description
The collection and transmission of electrocardiograms to a central data server using a wearable device were evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Vital Patch(TriBell Lab)Electrocardiograms were measured by VP-100 for more than 6 hours and transmitted to a central server. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adult male volunteers who can use an Android smartphone.
- The subjects who voluntarily agree to participate and give written informed consent.
Key exclusion criteria (2 listed)
- The subjects who have hypersensitivity to adhesives, such as medical bandages, or have clinically significant skin lesions.
- The subjects who are judged to be inappropriate for the clinical trials to participate.
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 |
|---|---|---|
| Vital Patch(TriBell Lab)Electrocardiograms were recorded using VP-100 for more than six hours and transmitted to a central data server located in Seoul National University Hospital. The data on a central server was confirmed and evaluated. | Device | Single arm |
Primary outcome
The proportion of data collected
Time frame: 6 hours
Compare actual monitored and server collected times
2 secondary outcomes
The comparison of ventricular rate
Time frame: 6 hours
The comparison of abnormal events
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Derived from this study: PubMed 35800668Huh KY, Jeong SI, Yoo H, Piao M, Ryu H, Kim H, Yoon YR, Seong SJ, Lee S, Kim KH. Lessons from a multicenter clinical trial with an approved wearable electrocardiogram: issues and practical considerations. Transl Clin Pharmacol. 2022 Jun;30(2):87-98. doi: 10.12793/tcp.2022.30.e7. Epub 2022 May 24.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vital Patch(TriBell Lab) in people with Arrhythmia, run by Seoul National University Hospital at 2 sites in South Korea.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SeungHwan Lee, Professor (82-02-2072-0694 ext. 0694, hwan8495@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of data collected (time frame: 6 hours). 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 NCT05182684, 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 10 Jan 2022.