A Three-phase Study That Will Compare the ECG Data Recorded Using the Test Device With the Data Recorded by a Reference Device, Evaluate the ECG Signal Quality of the Test Device Over a 10-day Simulated Use Period, and Assess the Effects of Variable ECG Electrode Placement for the Test Device

Summary

This clinical study will be performed in three phases.

The purpose of Phase 1 of this study is to compare the ECG data recorded using the ZywieZ3 Sensor and ZywieZ3 Adhesive ("Test Device") to the data recorded by a traditional 3-lead ECG device that uses wet Ag-AgCl adhesives in a standard lead location ("Reference Device"). The ECG signals will be recorded simultaneously with both ECG devices from the subjects in conditions that represent the devices' intended use for 1 hour. This comparison will determine whether the Test Device recordings are similar to the "gold standard" Reference Device. The testing methodology for this portion of the study is based on guidance provided by the FDA to the Sponsor.

The purpose of Phase 2 of this study is to evaluate the ECG signal quality of the Test Device over a 10-day simulated use period by human subjects. This duration of 10 days represents the expected maximum period of usage for the Test Device by the Sponsor. The skin adhesion properties of the Test Device will be evaluated, including a determination of whether any skin reactions, discoloration of the Test Device adhesive (including the snaps and hydrogel), or Test Device adhesive degradation leading to particulate formation occurs over a 10-day simulated use period by human subjects. During this testing, a human factor critical task analysis will be conducted via a collection of observational data regarding success in subject completion of Sponsor-identified critical tasks, subject completion of knowledge questionnaires relating to aspects of Sponsor-identified critical tasks, and subject completion of general subjective questionnaires regarding any difficulty they experienced with use of the Test Device. Testing methodology for this portion of the study is based upon the "Adhesive Performance (Duration of Use)" \[Section 5.4\] procedures from ANSI/AAMI Standard EC12:2000/(R)2020, Disposable ECG Electrodes and the 2016 FDA Guidance for Industry and Food and Drug Administration Staff titled "Applying Human Factors and Usability Engineering to Medical Devices."

The purpose of Phase 3 of this clinical study is to assess the effects of variable ECG electrode placement for the ZywieZ3 Sensor and ZywieZ3 Adhesive ("Test Device"). This testing is intended to determine whether ECG electrode placement variability produces unacceptable / non-clinically relevant ECG data and what level of ECG electrode placement variability is acceptable.

Conditions

• Healthy Subjects

Interventions

DEVICE

Phase 1 Test Device Sensor and Adhesive and Reference Device

Test Device Sensor and Adhesive and Reference Device ECG Data Collection for 1 hour

DEVICE

Phase 2 Test Device ECG Signal quality over a 10-day simulated use period

Evaluation of the ECG-signal quality of the Test Device sensor and adhesive applied to a single site on a subject's chest to collect ECG readings for a 10-day period.

DEVICE

Test Device Sensor and Adhesive Variable Placement

Comparison of nine incorrect locations of Test Device Sensor and Adhesive to the ideal location

Sponsors & Collaborators

• Zywie, Inc.

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-15

Primary Completion

2025-02-14

Completion

2025-02-14

FDA Device

Yes

Countries

• United States

Study Locations