Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04796181
Other study ID # NET-MED-002-EXT
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05483998 - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants Phase 1
Recruiting NCT02235012 - Cognitive Biases Under Ketamine N/A
Recruiting NCT02417714 - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Completed NCT05088343 - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects Phase 1
Completed NCT04418973 - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject. N/A
Not yet recruiting NCT06248801 - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets Phase 1
Terminated NCT04068259 - Single Ascending Dose Study of PBI-4547 in Healthy Subjects Phase 1
Completed NCT03279302 - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects Phase 1
Not yet recruiting NCT06233162 - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets Phase 1
Recruiting NCT04159844 - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects N/A
Completed NCT06137911 - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults. Phase 1
Completed NCT04849286 - Measurement of HTL0016878 in Cerebrospinal Fluid Phase 1
Not yet recruiting NCT06233227 - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule Phase 1
Completed NCT04096157 - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants Phase 1
Completed NCT01200368 - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants Phase 3
Recruiting NCT05805033 - Peri-Implant Soft Tissue Integration in Humans: Influence of Material N/A
Completed NCT04027803 - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® Phase 1
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT02903095 - Single Ascending Dose Study of TD-1439 in Healthy Subjects Phase 1
Active, not recruiting NCT02341508 - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers Phase 1