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

NCT07200232 | Completed FDA Device

• 1 other identifier: 2410001-150
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ECG Signal Quality Evaluation; Variable ECG Electrode Placement; Skin Adhesion of ECG Device and Adhesive; ECG Device and Adhesive versus Traditional ECG Device

Outcome Measures

Primary Outcomes (3)

• Phase 1: Test Device Sensor and Adhesive Equivalence to a Reference Device

  ECG recordings will be simultaneously collected from 25 subjects using the test and reference devices for one hour, during which subjects will perform a controlled activity for 55 minutes, including sitting, standing, and lying down. The clinical ECG interpretation will be performed independently by two board-certified cardiologists, with a third involved when there is a disagreement between the two. Two full-disclosure reports with de-identified ECG strips and timestamp information, one for each Test and Reference device, will be shared with the cardiologists. Each cardiologist will review reports and assess the overall quality of the ECG waveform, focusing on amplitude and morphology. The cardiologists will provide their assessment as 'Interpretable' with normal sinus rhythm, ectopy \[≤ 3 consecutive beats\], or any arrhythmia, or 'Uninterpretable' as noisy or not readable data. For each 3-minute ECG segment, a conclusion of 'equivalent or better' will be based on the assessments.

  From enrollment to end of the 1-hour ECG reading period

• Phase 2: Evaluate the ECG signal quality of the Test Device over a 10-day simulated use period by human subjects

  ECG recordings will be collected from 25 subjects using the ZywieZ3 device over 10 days. During this period, subjects will perform routine activities. For each subject, a report with ECG recordings from 10 days duration will be created. Each cardiologist will review the ECG data recorded and assess the clinical interpretability of the ECG waveform. Cardiologist will assess a page of data from every 12-hour window (consisting of 30 minutes of data) and stop if at least a 30-second ECG strip on a page is Interpretable. If all 30 minutes of data on the first page are Uninterpretable (noisy or unreadable), the clinician will continue until they find a page of data that includes at least one 30-second strip that is Interpretable. Of the pages that all cardiologists review, a page will be 'Interpretable' if two out of three cardiologists agree that the page is 'Interpretable'; otherwise the page will be 'Uninterpretable' when two out of three agree that the page is 'Uninterpretable'.

  From enrollment to 10 days after initial application of the Test Device

• Phase 3: Clinical equivalence of ECGs from different electrode placement positions compared to the control position of the Test Device

  Each subject will undergo 15 minutes of ECG recording under the standard placement (control) and each of the 9 variable placements/Test Positions. The clinical ECG interpretation will be performed by two board-certified cardiologists, with a third involved when there is a disagreement between the two. The cardiologists will provide their assessment for 15-minute recorded data from control and test positions using 'Interpretable' with normal sinus rhythm, ectopy \[≤ 3 consecutive beats\], or any arrhythmia, or 'Uninterpretable' with noisy or not readable data. Each cardiologist will review the ECGs of subjects from the control and test positions for 'equivalence.' Determination of 'equivalence' will be based on the assessment of the interpretability of the recording. To be equivalent at each 9 test positions, 2 out of 3 cardiologists must agree that the ECGs from control and test positions are 'Interpretable' or 'Uninterpretable.' Otherwise, ECGs are not equivalent.

  From enrollment to completion of data collection from all 10 positions performed in a single visit.

Secondary Outcomes (3)

• Test Device Data Quality

  Assessments performed after initial application and then 60-minutes and 10-days after application for Phase 1 and Phase 2. For Phase 3, assessments were performed for each of the 10 positions performed in a single day.

• Test Device Skin Adhesion Data

  Assessments performed after initial application, 60-minutes after application, and at completion of the 10-day wear time.

• Skin Condition

  Assessments performed after initial application, 60-minutes after application, and at completion of the 10-day wear time

Other Outcomes (1)

• Observations Regarding Test Device Electrode Discoloration / Presence of Particulates

  Assessments performed after removal of test day following a 10-day wear time

Study Arms (3)

Phase 1 Test Device Application and comparison to Reference Device

OTHER

Subjects apply Test Device Sensor and Adhesive according to instructions. Analysts apply Reference Device. Subject wears both devices for 1-hour with ECG Readings collected and compared between the two devices.

Device: Phase 1 Test Device Sensor and Adhesive and Reference Device

Phase 2 Test Device Sensor and Adhesive

OTHER

Test Device Sensor and Adhesive consisting of a single sensor applied to an adhesive than is then applied to the upper-left chest area of a subject for 10 days

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

Phase 3 Variable placement of the Test Device Sensor and Adhesive

OTHER

Assess the effects of variable ECG electrode placement for the Test Device Sensor and Adhesive for producing relevant ECG data

Device: Test Device Sensor and Adhesive Variable Placement

Interventions

Phase 1 Test Device Sensor and Adhesive and Reference Device DEVICE

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

Phase 1 Test Device Application and comparison to Reference Device

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

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.

Phase 2 Test Device Sensor and Adhesive

Test Device Sensor and Adhesive Variable Placement DEVICE

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

Phase 3 Variable placement of the Test Device Sensor and Adhesive

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Of the 25 subjects for Phase 1 and 2 and 20 subjects for Phase 3 who complete the study, at least 40% of subjects must be male, and at least 40% of the subjects must be female.
• Of the 25 subjects for Phase 1 and 2 and 20 subjects for Phase 3 who complete the study, no more than 50% may be white/Caucasian, and at least 50% must be classified as each of the following races: Asian, Black / African American, American Indian / Alaskan Native, and Native Hawaiian / Pacific Islander.
• Subjects must be 21 to 80 years of age. Of the 25 subjects for Phase 1 and 2 and 20 subjects for Phase 3 who complete the study, no more than 30% can be from a given quartile (21 to 36, 36 to 51, 51 to 65, and 65 to 80 year of age) of the age range.
• Subjects' body mass index (BMI) will be calculated based on their weight and height at the time of consent. BMI will be calculated using the CDC's online Adult BMI Calculator. This calculator will also automatically categorize the calculated BMI as underweight (\< 18.5), healthy (18.5 to 24.9), overweight (25.0 to 29.9), or obese (≥ 30.0). Of the 25 subjects for Phase 1 and 2 and 20 subjects for Phase 3 who complete the study, no more than 30% can be from a given BMI category.
• Subjects' education will be categorized as high school / GED, associate college degree, bachelor college degree, or post-graduate degree (e.g., M.S. or Ph.D.). Of the 25 subjects who complete Phases 1 and 2 of the study, no more than 7 subjects can be from a given educational level category.
• Of the 25 subjects who complete Phases 1 and 2 of the study, at least 7 must self-report some type of limited hand/arm dexterity.
• Subjects must be able to read, write, and understand English.
• Subjects must be in good general health (i.e., no current or recent severe illness).
• All subjects with body hair on their upper-left chest must be willing to have the body hair clipped by a Testing Facility analyst before application of the Test Device.
• Subjects participating in Phase 1 must be willing to have the body hair clipped by a Testing Facility analyst from the right clavicular region and middle of their left rib cage.
• Subjects participating in Phases 1 and 2 must be willing to clean the skin of the right clavicular region, upper-left chest, and middle of their left rib cage with 70% isopropanol preparation pads prior to their application of the Test Device and application of the Reference Device by a Testing Facility analyst. Subjects participating in Phase 3 must be willing to clean the skin of the upper-left chest with 70% isopropanol preparation pads before application of the Test Device.

You may not qualify if:

• Subjects cannot be currently participating in another clinical study.
• Subjects cannot have active skin rashes, dermatoses, or breaks in the skin on their clavicles, and the middle of their left rib cage for Phase 1 and 2 or on the upper left chest region for all phases.
• Subjects cannot have undergone any surgeries during the last 3 months involving incisions along their clavicles and the middle of their left rib cage for Phase 1 and Phase 2 or on the upper left chest region for all phases.
• Subjects cannot have any tattoos on their clavicles and the middle of their left rib cage for Phase 1 and Phase 2 or on the upper left chest region for all phases.
• Subjects cannot have currently inflammatory skin conditions (e.g., atopic dermatitis/eczema, contact dermatitis, or psoriasis) anywhere on the body within 2 days of the start of the test period and during the test period.
• Subjects cannot have a medical diagnosis of an organ transplant, medicated or uncontrolled diabetes, hepatitis B, hepatitis C, an immunocompromised condition such as AIDS (or HIV positive), lupus, medicated fibromyalgia, ulcerative colitis, Crohn's disease, moderate to severe asthma (requiring daily use of medication), or medicated multiple sclerosis.
• Subjects cannot have a pacemaker.
• Subjects cannot have any type of port, shunt, or Peripherally Inserted Central Catheter (PICC).
• Subjects cannot receive any vaccinations within 7 days of the start of the test period and while participating in the single-day or 10-day test period.
• Subjects cannot have known allergies or sensitivities to latex (natural rubber), adhesives, inks, sunscreens, deodorants, laundry detergents, cleansers, soaps, lotions, to topical application of fragrances (e.g., perfumes or colognes), acrylic, hydrogel, isopropyl alcohol, C11-12 isoparaffin, isopropyl palmitate, isopropyl myristate, or isopropyl stearate.
• Subjects participating in Phases 1 and 2 cannot use antihistamines within 2 days of the start of the test period through to the completion of the 10-day test period, which may interfere with the evaluation of skin reactions after application of the devices.
• Subjects cannot be pregnant or plan to become pregnant / impregnate a sexual partner during the study.
• Subjects cannot be nursing a child during the study.
• Subjects cannot have any medical condition or use any medications that, in the opinion of the Principal Investigator or Consulting Physicians, should preclude participation.

Sponsors & Collaborators

• Zywie, Inc.: lead

Study Sites (1)

Bioscience of Bozeman, LLC

Bozeman, Montana, 59715, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: For Phase 1 and Phase 2, a single group of at least 25 subjects will participate in both study phases, wearing a test and reference device for 1 hour and then the test device for a 10-day test period. For Phase 3, a single group of at least 20 subjects will participate in this study for a single test day with 15-minute ECG readings performed with the test device at the ideal location (control) and again with the test device applied to the skin in nine incorrect test locations/orientations (test positions).

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 1, 2025
• Study Start: January 15, 2025
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)