Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT07147920
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy
Sponsor:
Perin Health Devices
Organization:
Study Overview
Official Title:
Clinical Validation of the Perin Health Patch Electrocardiogram Monitoring Device: A Multi-Component Study Evaluating Signal Quality, Placement Tolerance, and Long-Term Performance
Status:
COMPLETED
Status Verified Date:
2025-08
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:
None
Brief Summary:
The goal of this clinical trial is to test how accurately and reliably a new chest-worn device called the Perin Health Patch measures heart rhythms (ECG) in adults aged 22 and older. The main questions it aims to answer are:
* How accurately does the Perin Health Patch measure heart rhythm compared to standard hospital ECG monitoring equipment?
* Does the patch still work properly if it's placed slightly off from the exact recommended position on the chest?
* Does the patch maintain good performance when worn continuously for 15 days?
The study has three parts that test different aspects of the device. Participants will:
* Wear the Perin Health Patch on their chest along with standard ECG monitoring equipment for comparison
* Have ECG recordings taken while sitting quietly for 15 minutes
* For the placement study: have the patch placed in several different positions to test if small placement errors affect performance
* For the long-term study: wear the patch continuously for 15 days at home with regular check-ups on days 1, 7, 10, and 15
The study will include both healthy adults and people with heart or lung conditions like heart failure, COPD, high blood pressure, or diabetes to test how well the device works for different types of patients. Researchers will compare the heart rhythm measurements from the chest patch to standard medical monitoring equipment to determine if the patch is accurate enough for medical use. Some participants will complete just one part of the study, while others may participate in multiple parts depending on which aspect of the device is being tested.
* How accurately does the Perin Health Patch measure heart rhythm compared to standard hospital ECG monitoring equipment?
* Does the patch still work properly if it's placed slightly off from the exact recommended position on the chest?
* Does the patch maintain good performance when worn continuously for 15 days?
The study has three parts that test different aspects of the device. Participants will:
* Wear the Perin Health Patch on their chest along with standard ECG monitoring equipment for comparison
* Have ECG recordings taken while sitting quietly for 15 minutes
* For the placement study: have the patch placed in several different positions to test if small placement errors affect performance
* For the long-term study: wear the patch continuously for 15 days at home with regular check-ups on days 1, 7, 10, and 15
The study will include both healthy adults and people with heart or lung conditions like heart failure, COPD, high blood pressure, or diabetes to test how well the device works for different types of patients. Researchers will compare the heart rhythm measurements from the chest patch to standard medical monitoring equipment to determine if the patch is accurate enough for medical use. Some participants will complete just one part of the study, while others may participate in multiple parts depending on which aspect of the device is being tested.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: