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This study will be conducted to collect anatomical data in an ambulatory healthy population to aid in the development of a novel non-invasive technology to assess changes in lung hydration status. It will also help in developing reference ranges of lung hydration status in healthy subjects and their associated changes with time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects without heart failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMED-4 | Device | Non-invasive novel lung hydration status sensor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Data Collection | The primary endpoint is successful IMED-4 recordings at multiple timepoints from one hundred (100) unique subjects. A recording will be considered successful if it meets IMED-4 recording quality indicators. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from the general population using various media advertising as well as through a site database. Potential subjects aged older than 30 will be recruited for a telephone interview. If they qualify based on a very brief screening interview regarding their suitability as a participant, and they are interested in participating, they will be scheduled to visit the Intersection Medical, Inc., corporate office. If they decline to participate, no further contact will be initiated.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intersection Medical Inc. | Carlsbad | California | 92008 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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