Healthy SubjectsNCT04796181
Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device
An observational study of Healthy Subjects and Chronic Conditions, Multiple, run by Neteera Technologies Ltd. at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Chronic Conditions, Multiple
- What is being tested?
- Neteera 130H
- Type of treatment
- Medical device
- How many people
- 170 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Feb 2021to 2 Jul 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and females, 18 years old and above willing and able to provide an informed consent and eligible according to the eligibility criteria.
Who may be able to join
- Age ≥ 18 years
- Age ≥ 18 years
- One (or more) chronic medical condition/s
Who cannot join
- 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
Show all 11Show fewer
- Subjects that will not be able to complete the trial, according to the PI or SI evaluation
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the 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 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.
- Conditions
- Healthy Subjects, Chronic Conditions, Multiple
- Being tested
- Neteera 130H
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neteera 130HDevice
The Neteera 130H will used to perform measurements in proximity to study participants.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During 60 seconds, from t = 0:00 min to t = 1:00
Secondary outcomes (3)
Repeating the primary endpoints in sitting position while the investigated device is located in front of the subject.
- Repeating the primary endpoints in sitting position while the investigated device is located in front of the subject.
Measured: 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.
Repeating the previous endpoints (where applicable) in sleep posture/lying in bed position, while the investigated device is located above of the subject.
Measured: 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
Measured: During 5 minutes of the continuous measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start21 Feb 2021
- Primary completion25 Mar 2022
- Study completion2 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Neteera Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Bertoch, MD, Principal investigator, JBR Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796181
- Sponsor's protocol ID
- NET-MED-002-EXT
- Status last verified
- Feb 2022
- First submitted
- 8 Mar 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04796181
- Acronym / sponsor ID
- NET-MED-002-EXT
- Conditions
- Healthy Subjects, Chronic Conditions, Multiple
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Neteera Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 2 Jul 2022 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females, 18 years old and above willing and able to provide an informed consent and eligible according to the eligibility criteria.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Age ≥ 18 years
- One (or more) chronic medical condition/s
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neteera 130HThe Neteera 130H will used to perform measurements in proximity to study participants. | Device | – |
Primary outcome
Proportion of accurate spot HR while the Neteera 130H located behind the subject.
Time frame: During 60 seconds, from t = 0:00 min to t = 1:00
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
Proportion of accurate spot RR while the Neteera 130H located behind the subject.
Time frame: During 60 seconds, from t = 0:00 min to t = 1:00
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
3 secondary outcomes
Repeating the primary endpoints in sitting position while the investigated device is located in front of the subject.
Time frame: 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.
Time frame: During 60 seconds
Repeating previous endpoint positions (where applicable) comparing investigated device continuous HR and RR measurements to reference device continuous measurements
Time frame: During 5 minutes of the continuous measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Bertoch, MD principal investigator
JBR Clinical Research
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects and Chronic Conditions, Multiple, run by Neteera Technologies Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of accurate spot HR while the Neteera 130H located behind the subject. (time frame: During 60 seconds, from t = 0:00 min to t = 1:00). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.