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Status unknownNCT05182684Updated Jan 10, 2022

The Collection and Transmission of Electrocardiogram Using a Wearable Device

An interventional study of Vital Patch(TriBell Lab) in Arrhythmia, sponsored by Seoul National University Hospital. Status unknown at 2 sites in Korea, Republic of. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-10.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Arrhythmia

Browse trials for

03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's planned enrollment of 50 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adult male volunteers who can use an Android smartphone.
  • The subjects who voluntarily agree to participate and give written informed consent.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Single arm

    Electrocardiograms were measured by VP-100 for more than 6 hours and transmitted to a central server.

    Device: Vital Patch(TriBell Lab)

Interventions

  • DeviceVital 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.

06

What researchers measure

Primary outcomes

  1. The proportion of data collected

    Compare actual monitored and server collected times

    Time frame: 6 hours

Secondary outcomes

  1. The comparison of ventricular rate

    Compare actual monitored and server collected ventricular rate

    Time frame: 6 hours

  2. The comparison of abnormal events

    Compare patient-reported adverse events with abnormal beats collected by a central server

    Time frame: 6 hours

07

Study locations

2 of 2 sites recruiting
  • Seoul National University Hospital Clinical Trial Center
    Seoul, 03080, Korea, Republic of
    Recruiting
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05182684
Lead sponsor
Seoul National University Hospital
Responsible party
SeungHwan Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 10, 2022
Start date
Oct 26, 2021
Primary completion
Jun 21, 2022 (estimated)
Completion
Jun 21, 2022 (estimated)
Last update
Jan 10, 2022

Study contacts

SeungHwan Lee, Professor
Contact
hwan8495@snu.ac.kr
82-02-2072-0694 ext. 0694

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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