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The purpose of this research is to validate the prototype AI-Flex device. Researchers at Mayo Clinic developed a new a flexible multi-modal bio-sensing device, AI-Flex, with integrated artificial intelligence (AI) capability. Integration of sensing and AI analysis on the same device removes the need for data storage on the cloud for later analysis. The goal of the device is to allow real-time monitoring of patient health and timely intervention based on patient health condition. It is hoped that the proposed flexible device will allow intimate skin contact using ultra-thin (<10 µm) geometry to reduce or eliminate relative movement between the skin and flexible epidermal sensors even during rapid motion of the subject, which would significantly improve the sensor signal quality for AI analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-Modal Sensor Patch Measurements | Experimental | Subjects referred to Mayo Clinic in Arizona Cardiology Clinic who have an underlying cardiac structural condition will have a 15-minute data collection via the prototype device, AI-Flex, and standard of care electrocardiogram (ECG), temperature, and photoplethysmogram (PPG) measurements. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-Flex | Device | A flexible multi-modal bio-sensing device with integrated AI capability used to measure ECG (heart's electrical activity), body temperature, and PPG (blood volume in tissue); primarly mounted on the wrist and chest. |
| Measure | Description | Time Frame |
|---|---|---|
| AI-Flex ECG Accuracy | Number of AI-Flex ECG interpretations to match the standard of care commercial ECG recording | Baseline |
| AI-Flex Temperature Measurement Accuracy | Number of AI-Flex ECG interpretations to match the standard of care commercial temperature measurement | Baseline |
| AI-Flex PPG Measurement Accuracy | Number of AI-Flex ECG interpretations to match the standard of care commercial photoplethysmogram (PPG) measurement | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
- < 18 years of age or > 85 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Imon Banerjee, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imon Banerjee | Phoenix | Arizona | 85054-4533 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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