Status:
COMPLETED
Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device
Lead Sponsor:
Neteera Technologies Ltd.
Conditions:
Healthy Subjects
Chronic Conditions, Multiple
Eligibility:
All Genders
18+ years
Brief Summary
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 respi...
Detailed Description
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 comp...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 2 2022
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04796181
Start Date
February 21 2021
End Date
July 2 2022
Last Update
October 5 2022
Active Locations (2)
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1
JBR Clinical Research
Millcreek, Utah, United States, 84107
2
Shaare Zedek Medical Center
Jerusalem, Israel