Back to resultsThe Collection and Transmission of Electrocardiogram Using a Wearable Device
Primary Purpose
Arrhythmia
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vital Patch(TriBell Lab)
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrhythmia
Eligibility Criteria
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.
Sites / Locations
- Seoul National University Hospital Clinical Trial CenterRecruiting
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Electrocardiograms were measured by VP-100 for more than 6 hours and transmitted to a central server.
Outcomes
Primary Outcome Measures
The proportion of data collected
Compare actual monitored and server collected times
Secondary Outcome Measures
The comparison of ventricular rate
Compare actual monitored and server collected ventricular rate
The comparison of abnormal events
Compare patient-reported adverse events with abnormal beats collected by a central server
Full Information
NCT ID
NCT05182684
First Posted
October 25, 2021
Last Updated
December 21, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05182684
Brief Title
The Collection and Transmission of Electrocardiogram Using a Wearable Device
Official Title
A Multi-center Clinical Trial to Explore the Status of Collection and Transmission of Electrocardiogram Using a Wearable Device
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
June 21, 2022 (Anticipated)
Study Completion Date
June 21, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
Electrocardiograms were measured by VP-100 for more than 6 hours and transmitted to a central server.
Intervention Type
Device
Intervention Name(s)
Vital Patch(TriBell Lab)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of data collected
Description
Compare actual monitored and server collected times
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
The comparison of ventricular rate
Description
Compare actual monitored and server collected ventricular rate
Time Frame
6 hours
Title
The comparison of abnormal events
Description
Compare patient-reported adverse events with abnormal beats collected by a central server
Time Frame
6 hours
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SeungHwan Lee, Professor
Phone
82-02-2072-0694
Ext
0694
Email
hwan8495@snu.ac.kr
Facility Information:
Facility Name
Seoul National University Hospital Clinical Trial Center
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
In-Jin Jang, MD, PhD
Phone
+82-2-2072-1910
Email
ijjang@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Kyung-Sang Yu, MD, PhD
Phone
+82-2-2072-1920
Email
ksyu@snu.ac.kr
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Il Song Choi, Doctor
Phone
82-10-9899-3468
Email
jgsaim88@snu.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35800668
Citation
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.
Results Reference
derived
Learn more about this trial
The Collection and Transmission of Electrocardiogram Using a Wearable Device
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