NCT06896734

mobiCARE™ ECG Monitoring System

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Seers Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• ECG Monitoring

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-02-05
• Completion: 2025-03-16
• First posted: 2025-03-26
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

1 site across 1 country: United States