mobiCARE™ ECG Monitoring System (SEERS)

April 23, 2025 updated by: Seers Technology Co., Ltd.

Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study

Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the Seers Technology Company Ltd. sponsored study using the mobiCARE™ ECG Monitoring System is to document the variability and interpretability of heart rhythm tracings from the nominal position whereby the mobiCARE™ device is still able to obtain interpretable ECG signals, in a cohort of adults representative of the U.S. population.

Informational data will be collected, such as P-wave amplitude and QRS amplitude and duration to note any morphological ECG signal changes. Human factors (HF) endpoints will be evaluated including: HCP placement according to IFU, subject demonstration of changing electrodes, dexterity for user to perform the task, electrode placement according to skin markings, and the ability of the user to remove and replace the mobiCARE™ device.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • MCB Clinical Research Centers, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include adults who are asymptomatic or who may suffer from transient symptoms such as arrhythmias and/or palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety; ranging in age, ethnic group, BMI, educational level and gender.

Description

Inclusion Criteria:

  1. Male and female adults ≥ 18 years of age;
  2. Willing and able to provide informed consent;
  3. Able to speak and read English fluently;
  4. Participant is ambulatory.

Exclusion Criteria:

  1. Patients with cardiac pacemaker;
  2. Patients with cardioverter defibrillator;
  3. Patients with other implantable electric devices;
  4. Currently or has a medical history of skin cancer, rash, skin disorder, keloid, and/or any injury in the chest area;
  5. Patients with symptomatic episodes where variations in cardiac performance could result in immediate danger to the patient;
  6. Patients with known history of life-threatening arrhythmias;
  7. Use in combination with external cardiac defibrillators or high frequency surgical equipment near strong magnetic fields or devices such as MRI;
  8. Patients with neuro-stimulator, as it may disrupt the quality of ECG data;
  9. Critical care patients;
  10. Chest pain at the time of presentation for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The study population will include adults who are asymptomatic or who may suffer from transient sympt
The study population will include adults who are asymptomatic or who may suffer from transient symptoms such as arrhythmias and/or palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety; ranging in age, ethnic group, BMI, educational level and gender.
Device: Evaluation of the ECG signal in the nominal location and in three alternate positions
Evaluation of the ECG signal in the nominal location and in three alternate positions to determine if the three alternate positions are interpretable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects in Which the ECG Signal is Interpretable at the Nominal Location and up to 3 Alternate Positions
Time Frame: 2 minutes while the patient ambulates

Evaluation of the ECG signal at the nominal location and in up to three (3) additional alternate positions (AP) in each subject to determine if the signal is interpretable. The term "interpretable" is defined as follows: An independent cardiologist reader is able to identify the ECG rhythm in each location when compared to the ECG rhythm measured in the nominal position of the mobiCARE™ Cardiac Monitoring System described in the Instructions for Use. ECG rhythm data will be collected for up to two (2) minutes while the patient ambulates.

ECG rhythm data were collected in each location during normal use for at least two (2) minutes while the subject was sitting, standing, and ambulating.

The simultaneous Holter Monitor will be measured at the same time points to have a point of reference for the mobiCARE™ system in the case that changes in the rhythm are noted on the mobiCARE™ Cardiac Monitoring System during the study.
2 minutes while the patient ambulates

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Artifact Graded
Time Frame: 2 minutes
Presence of artifact graded as 1=none, 2=minor (cardiac rhythm is interpretable), or 3=major (cardiac rhythm is not interpretable by the independent cardiologist).
2 minutes
Evaluation of the ECG Morphology Measurements at the Nominal Position and up to 3 Alternate Positions
Time Frame: 2 Minutes
The number of measurable positions for QRS amplitude and QRS duration at the nominal position and up to 3 alternate positions.
2 Minutes
Human Factors Evaluation Measures
Time Frame: 2 Minutes
Usability Performance Evaluation for Health Care Professionals and Subjects
2 Minutes
The Number of Measurable Positions for P-waves
Time Frame: 2 minutes
Informational data collected to evaluate interpretability based on P-wave amplitude
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seers Technology Co., Ltd.

Collaborators

Eminence Clinical Research, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

February 5, 2025

Study Completion (Actual)

March 16, 2025

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SEER-CLIN-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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