Healthy Subjects Clinical Trial
Official title:
Single Center, 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
Verified date | February 2022 |
Source | Neteera Technologies Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | July 2, 2022 |
Est. primary completion date | March 25, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria (NET-MED-002): - Age = 18 years Inclusion Criteria (NET-MED-002-EXT): - Age = 18 years - One (or more) chronic medical condition/s Exclusion Criteria (NET-MED-002): - Children under the age of 18 years - Pregnant or lactating women - as confirmed by a home pregnancy test kit - Current irregular heart rate (e.g. Atrial fibrillation) - as assessed by a targeted physical examination during screening - Current shortness of breath, respiratory distress, or other clinical signs of hemodynamic instability - as assessed by a targeted physical examination during screening - Prior major surgical and/or orthopedical and/or trauma in the thorax - Participation in an investigational trial within 30 days of the screening visit - Subjects that will not be able to complete the trial, according to the PI or SI evaluation Exclusion Criteria (NET-MED-002-EXT) - Children under the age of 18 years - Prior major trauma in the thorax - Participation in an investigational trial within 30 days of the screening visit - Subjects that will not be able to complete the trial, according to the PI or SI evaluation |
Country | Name | City | State |
---|---|---|---|
Israel | Shaare Zedek Medical Center | Jerusalem | |
United States | JBR Clinical Research | Millcreek | Utah |
Lead Sponsor | Collaborator |
---|---|
Neteera Technologies Ltd. |
United States, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety Endpoint | Percent of subjects with device related adverse events. | from screening until the end of study measurements | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Repeating the previous endpoints (where applicable) in sleep posture/lying in bed position, while the investigated device is located above of the subject. | 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 | |
Secondary | 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 |
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