HealthyNCT04676152
Validation of Noninvasive Blood Pressure Device
A study testing Masimo Noninvasive Blood Pressure Device in people with Healthy and Hypertension, run by Masimo Corporation at 2 sites in United States.
Trial summary
This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers. The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory 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, Hypertension, Hypotension
- What is being tested?
- Masimo Noninvasive Blood Pressure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Oct 2020to 2 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age 18 years and older
- Site 1; Stage 1 only: Subjects with a history of hypertension (> 140/85 mmHg) or hypotension (< 100/60 mmHg) within the last 3 months. Stage 2 only: No criterion for blood pressure
- Site 2; Stage 1 and 2: Subjects with systolic blood pressure < 140/90 mmHg.
- Ability to provide informed consent
Who cannot join
- Febrile subjects
- Subjects displaying respiratory symptoms, or with suspected respiratory illness
- Subjects whose skin is not intact, e.g. wounded, in or at the vicinity of the cuff placement site
- Subjects with removed axillary lymph nodes or mastectomies
- Subjects with peripheral artery disease
- Pregnant women (patient reported)
- Subjects deemed not suitable for the study at the discretion of the investigator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Site 2
Irvine, California, 92618
Site 1
Lomita, California, 90717
About this study
This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers.
The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.
- Conditions
- Healthy, Hypertension, Hypotension
- Being tested
- Masimo Noninvasive Blood Pressure Device
- Medical subject headings
- Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Noninvasive Blood Pressure DeviceDevice
Non-invasive blood pressure device
| Study group | Role | What they receive |
|---|---|---|
| Test subjects | Experimental | All subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device. Receives: Device: Masimo Noninvasive Blood Pressure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements.
Performance will be determined by calculating the mean and standard deviation of the differences between the systolic and diastolic blood pressure measurements obtained from Masimo NIBP device and manual sphygmomanometer.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start5 Oct 2020
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676152
- Sponsor's protocol ID
- TORR0004
- Status last verified
- Jan 2024
- First submitted
- 5 Nov 2020
- Last updated
- 8 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Noninvasive Blood Pressure Device
- ClinicalTrials.gov ID
- NCT04676152
- Acronym / sponsor ID
- TORR0004
- Conditions
- Healthy, Hypertension, Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers.
The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test subjects | Experimental | Device: Masimo Noninvasive Blood Pressure DeviceAll subjects enrolled had blood pressure measurements taken using the noninvasive blood pressure device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years and older
- Site 1; Stage 1 only: Subjects with a history of hypertension (> 140/85 mmHg) or hypotension (< 100/60 mmHg) within the last 3 months. Stage 2 only: No criterion for blood pressure
- Site 2; Stage 1 and 2: Subjects with systolic blood pressure < 140/90 mmHg.
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- Febrile subjects
- Subjects displaying respiratory symptoms, or with suspected respiratory illness
- Subjects whose skin is not intact, e.g. wounded, in or at the vicinity of the cuff placement site
- Subjects with removed axillary lymph nodes or mastectomies
- Subjects with peripheral artery disease
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 |
|---|---|---|
| Masimo Noninvasive Blood Pressure DeviceNon-invasive blood pressure device | Device | Test subjects |
Primary outcome
Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements.
Time frame: 1 hour
Performance will be determined by calculating the mean and standard deviation of the differences between the systolic and diastolic blood pressure measurements obtained from Masimo NIBP device and manual sphygmomanometer.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
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
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Masimo Noninvasive Blood Pressure Device in people with Healthy and Hypertension, run by Masimo Corporation at 2 sites in United States.
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 4 inclusion and 7 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 8 Jan 2024. 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. 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?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. (time frame: 1 hour). 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 8 Jan 2024.