NCT04100668

Completed

Evaluation of Sensifree's Alpha Sensor Signal Morphology Com...

Sensifree Ltd.Source

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Other study identifiers

Sponsor study identifier

PR2017-240

Study Type

interventional

Actual enrollment (reported)

15

Locations

1 country

Sites

1

Timeline

Study Start

September 26, 2017

Actual (reported)

Primary Completion

September 29, 2017

Actual (reported)

Study Completion

September 29, 2017

Actual (reported)

Brief Summary

The purpose of the protocol is to compare Sensifree Alpha sensor signal morphology, measured at the radial artery, to an invasive arterial line pressure signal and the oxygen saturation as read by a pulse oximeter. The study will be split into two phases: the first phase will collect data for morphology analysis and algorithm development, the second phase will compare device performance to the reference invasive blood pressures. A secondary objective is to evaluate signal morphology changes due to changes in subject arm position.

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): 15 participants
Study completion date: September 29, 2017
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
September 26, 2017
Actual (reported)
Primary Completion
September 29, 2017
Actual (reported)
Study Completion
September 29, 2017
Actual (reported)
First Submitted
March 28, 2018
Actual (reported)
First Posted
September 24, 2019
Actual (reported)

Last Updated: September 24, 2019
Status Verified: September 2019
Last Update Submitted: September 20, 2019

Conditions

Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

Comparison of signals acquired from the investigational device, pulse oximeter, and arterial line
BP waveform will be acquired form three sources (PPG, A-line and investigational device),data will be statistically analyzed to find the correlations between the different sources of BP waveform
Three hours

Secondary Outcomes (1)

Evaluation of waveform signal changes with different arm positions
Three hours

Study Arms (1)

Data collection

EXPERIMENTAL

Comparing radial arterial line, Sensifree's Alpha sensor and PPG sensor pressure waveforms

Device: Sensifree's Alpha sensorDevice: Arrow® arterial catheterization kit (Teleflex)Device: GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor

Interventions

Sensifree's Alpha sensorDevice

RF based, wrist mounted sensor, that acquires a high fidelity signal originating at the radial artery, and constructs a pressure waveform

Data collection

Arrow® arterial catheterization kit (Teleflex)Device

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

Data collection

Eligibility Criteria

Age20 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

General:
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

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 28, 2018

First Posted

September 24, 2019

Study Start

September 26, 2017

Actual (reported)

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Not ApplicableRecruiting

NCT07739667

Blood Pressure Measurement Using Vitacam

Recruiting

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

Data collection

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

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

Screening and Phase 1:

Subject is from 20 to 55 years old.

Subject has wrist circumference size within 145 and 220mm for both arms.

Subjects with lateral blood pressure difference (auscultatory cuff based measurement) is less than: 15 mmHg for systolic blood pressure. 10 mmHg for diastolic blood pressure.

Subjects with investigational device signal quality higher than a predefined value

Subjects with similar investigational devices signals between their two arms.

Phase 2 (all requirements as Phase 1 except):

Subject is from 20 to 85 years old.

At least 60% of subjects will have hypertensive blood pressure values (goal) (systolic \>140 mmHg and/or diastolic \>90 mmHg)

At least 15% of subjects will have hypotensive blood pressure values (goal) (systolic \<110 mmHg and/or diastolic \<60 mmHg).

No more than 25% of subjects will have normotensive blood pressure values (goal) (systolic from 110 to 140 mmHg and/or diastolic from 60 to 90 mmHg).

You may not qualify if:

Subject with a BMI over 39
Deformities or abnormalities that may prevent proper application of the device under test
Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
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
Chest pain (angina)
Abnormal pulse pressure
+33 more criteria

Contact the study team to confirm eligibility.

Primary Completion

September 29, 2017

Actual (reported)

Study Completion

September 29, 2017

Actual (reported)

Last Updated

September 24, 2019

Record last verified: 2019-09

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: NCT04100668
Data provider: ClinicalTrials.gov
Source updated: 2019-09-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:31 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)

Study Arms (1)

Data collection

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