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A single center, single blinded, prospective validation (including extension0 study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements.
This is a single-blinded, prospective validation study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements compared to reference devices.
Each subject will have a single study visit in which the subjects will be screened and upon eligibility confirmation, will undergo HR and RR measurements using the investigational device as well as the reference devices. In a previous clinical trial (NET-MED-002) 100 subjects were measured in the sitting position. In the extension study part (NET-MED-002-EXT), 70 eligible subjects, 18 years old and above, suffering from chronic medical conditions, will be enrolled. In this extension part, 70 of the subjects will be measured while randomly assigned into one of two groups - 35 subjects in group A (sitting position) and 35 subjects in sleep posture//group B (lying in bed/sleeping posture position) in a ratio of 1:1. Data from the previous study and the Extension study will be pooled for final analysis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neteera 130H | Device | The Neteera 130H will used to perform measurements in proximity to study participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of accurate spot HR while the Neteera 130H located behind the subject. | Proportion of accurate spot HR (BPM) measurements of the investigated device, while located behind the subject, in sitting position compared to the reference device measurements | During 60 seconds, from t = 0:00 min to t = 1:00 |
| Proportion of accurate spot RR while the Neteera 130H located behind the subject. | Proportion of accurate spot RR (BrPM) measurements of the investigated device in sitting position, while located behind the subject, compared to reference device (capnograph) measurements | During 60 seconds, from t = 0:00 min to t = 1:00 |
| Measure | Description | Time Frame |
|---|---|---|
| Repeating the primary endpoints in sitting position while the investigated device is located in front of the subject. | 1) Repeating the primary endpoints in sitting position while the investigated device is located in front of the subject. | During 60 seconds, from t = 0:00 min to t = 1:00 |
| Repeating the previous endpoints (where applicable) in sleep posture/lying in bed position, while the investigated device is located above of the subject. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | Percent of subjects with device related adverse events. | from screening until the end of study measurements |
Inclusion Criteria (NET-MED-002):
Inclusion Criteria (NET-MED-002-EXT):
Exclusion Criteria (NET-MED-002):
Exclusion Criteria (NET-MED-002-EXT)
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Males and females, 18 years old and above willing and able to provide an informed consent and eligible according to the eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Todd Bertoch, MD | JBR Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JBR Clinical Research | Millcreek | Utah | 84107 | United States | ||
| Shaare Zedek Medical Center |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Repeating the previous endpoints (where applicable) in sleep posture/lying in bed position, while the investigated device is located above of the subject. |
| During 60 seconds |
| Repeating previous endpoint positions (where applicable) comparing investigated device continuous HR and RR measurements to reference device continuous measurements | Repeating previous endpoint positions (where applicable) comparing investigated device continuous HR and RR measurements to reference device continuous measurements | During 5 minutes of the continuous measurement |
| Jerusalem |
| Israel |