The Collection and Transmission of Electrocardiogram Using a Wearable Device

NCT ID: NCT05182684

Last Updated: 2022-01-10

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-26

Study Completion Date

2022-06-21

Brief Summary

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A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device

Detailed Description

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The collection and transmission of electrocardiograms to a central data server using a wearable device were evaluated.

Conditions

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Arrhythmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm

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

Group Type EXPERIMENTAL

Vital Patch(TriBell Lab)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

* 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.
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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SeungHwan Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital Clinical Trial Center

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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SeungHwan Lee, Professor

Role: CONTACT

82-02-2072-0694 ext. 0694

Facility Contacts

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In-Jin Jang, MD, PhD

Role: primary

+82-2-2072-1910

Kyung-Sang Yu, MD, PhD

Role: backup

+82-2-2072-1920

Il Song Choi, Doctor

Role: primary

82-10-9899-3468

References

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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.

Reference Type DERIVED
PMID: 35800668 (View on PubMed)

Other Identifiers

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VP-100-ECG

Identifier Type: -

Identifier Source: org_study_id

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