NCT04456179

Completed

Continuous Non-Invasive Blood Pressure System Data Collectio...

Sensifree Ltd.Source

Compare

Other study identifiers

Sponsor study identifier

PR2020-363

Study Type

interventional

Actual enrollment (reported)

6

Locations

1 country

Sites

1

Timeline

Study Start

February 3, 2020

Actual (reported)

Primary Completion

February 6, 2020

Actual (reported)

Study Completion

February 6, 2020

Actual (reported)

Brief Summary

The purpose of this study is to evaluate methods to modify blood pressure in humans and measure the effectiveness of such methods. A secondary outcome is to evaluate the performance of an investigational continuous non-invasive blood pressure (cNIBP) device created by Sensifree. The tests will per performed in non-hospitalized subjects under varied controlled conditions that include resting blood pressure and non-pharmacologically induced blood pressure changes.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 6 participants
Study completion date: February 6, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 3, 2020
Actual (reported)
Primary Completion
February 6, 2020
Actual (reported)
Study Completion
February 6, 2020
Actual (reported)
First Submitted
June 3, 2020
Actual (reported)
First Posted
July 2, 2020
Actual (reported)

Last Updated: July 2, 2020
Status Verified: June 2020
Last Update Submitted: June 29, 2020

Conditions

Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans
Measure the effect of a combination of the following isometric efforts on a subject's blood pressure (measured in mmHg): 1. Hand grip 2. Weight lifting 3. Leg static effort
3-4 hours per subject

Secondary Outcomes (1)

Measure the accuracy of an investigational continuous non-invasive blood pressure (cNIBP) device
3-4 hours per subject

Interventions

GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter SensorDevice

PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform

Arrow® arterial catheterization kit (Teleflex)Device

Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall(Gender-based eligibility)

Gender Eligibility DetailsAt least 30% of the subjects will be female and at least 30% will be male

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subject must have the ability to understand and provide written informed consent

Sponsors & Collaborators

Sensifree Ltd.
Industrylead

Study Sites (1)

Clinimark Lab

Louisville, Colorado, 80027, United States

Study Officials

Arthur Ruiz Cabrera, M.D
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

July 2, 2020

Study Start

February 3, 2020

Actual (reported)

NCT04132453

Continuous Blood Pressure and Waveform Measurements Comparison Between Invasive Arterial Line and PPG Sensor

Completed

NCT07901608

Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study

Recruiting

NCT06915376

"AI-Based Noninvasive Blood Pressure Monitoring Compared to Invasive Arterial Measurement"

Completed

NCT07628296

Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations

Not ApplicableRecruiting

NCT07739667

Blood Pressure Measurement Using Vitacam

Recruiting

NCT07697950

NIBP Accuracy Study for Adult Subject Populations

Not ApplicableRecruiting

Subject must be willing and able to comply with study procedures and duration

You may not qualify if:

Subject with a BMI over 39
Deformities or abnormalities that may prevent proper application of the device under test
Lateral difference in blood pressure greater than 5mmHg diastolic and 9mmHg systolic
Tachycardia or resting heart rate less than 45 bpm
Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential)
Subjects with known respiratory conditions such as: (self-reported)
uncontrolled / severe asthma,
flu,
pneumonia / bronchitis,
shortness of breath / respiratory distress,
respiratory or lung surgery,
emphysema, COPD, lung disease
Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
have had cardiovascular surgery
have cardiac pacemakers and/or automatic internal cardio-defibrillator
+34 more criteria

Contact the study team to confirm eligibility.

Primary Completion

February 6, 2020

Actual (reported)

Study Completion

February 6, 2020

Actual (reported)

Last Updated

July 2, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04456179
Data provider: ClinicalTrials.gov
Source updated: 2020-07-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:17 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations