Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04796181
• Other study ID #: NET-MED-002-EXT
• Status: Completed
• Start date: February 21, 2021
• Est. completion date: July 2, 2022

Study information

• Verified date: February 2022
• Source: Neteera Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 respiratory rate measurements.

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 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Healthy Subjects
• Multiple Chronic Conditions

Intervention

Device:
• Neteera 130H
The Neteera 130H will used to perform measurements in proximity to study participants.

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem
United States	JBR Clinical Research	Millcreek	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Neteera Technologies Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

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