Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-30 @ 12:13 PM
Study NCT ID:
NCT06896734
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2025-02-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
mobiCARE™ ECG Monitoring System
Sponsor:
Seers Technology Co., Ltd.
Organization:
Study Overview
Official Title:
Evaluation of the mobiCARE™ ECG Monitoring System Electrode Placement Positioning Limits in a Prospective, Non-Randomized, Single-Center U.S. Study
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEERS
Brief 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: