NCT07200232View on ClinicalTrials.gov

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

NACompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

February 14, 2025

Study Completion Date

February 14, 2025

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

Trial Locations (1)

59715

Bioscience of Bozeman, LLC, Bozeman

All Listed Sponsors
lead

Zywie, Inc.

INDUSTRY

NCT07200232 - 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 | Biotech Hunter | Biotech Hunter