Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
Study NCT ID:
NCT04100668
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2018-03-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Sensifree's Alpha Sensor Signal Morphology Compared to Arterial Line and PPG Signal Morphologies
Sponsor:
Sensifree Ltd.
Organization:
Study Overview
Official Title:
Evaluation of Sensifree's Alpha Sensor Signal Morphology in Comparison to Invasive Radial Arterial Line Pressure Waveform and PPG Signal Morphology
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
This study is a single-center, non-randomized study with a maximum of 50 subjects. The duration of the study for each subject test is expected to take approximately 3 hours: 1 hour for screening (Visit 1) and 2 hours for data collection (Visit 2).
Data Collection, Visit 2, will be divided into two phases. Phase 1 will use up to 20 subjects with the goal of collecting data for algorithm and sensor development. No requirements for certain blood pressure populations are required for Phase 1. Once the analysis of the Phase 1 results is complete, Phase 2 will use up to 30 subjects with the following requirements to test multiple blood pressure populations:
* No more than 25% will be normotensive
* At least 60% of the subjects will be hypertensive
* At least 15% of the subjects will be hypotensive
Visit 1- Screening Screening will be identical for both phases of the study. Subjects will be screened for per the inclusion criteria, assuring the subject will be a good candidate for the data collection portion of the study. If the subject does not meet the inclusion criteria they will not be invited to participate in Visit 2. During screening, the subject's wrist circumference will be recorded and measured for each arm. The clinician will perform auscultatory blood pressure measurements on both arms to determine the lateral systolic and diastolic blood pressure difference per Procedure 5.2.4.3.1. in the International Standards Organization (ISO) 81060-2:2013. Using ultrasound, the clinician will also determine if the subject has any bifurcations in the radial artery of each arm. Finally, the investigation devices will be place on both wrists of the subject to determine if adequate signal can be detected. If the subject meets all the inclusion criteria for screening they will be invited to participate in the data collection portion of the study during Visit 2.
Visit 2- Screening Visit 2, the data collection portion of the study, will begin with the volunteer test subject lying in the supine position. The subject will be reminded they may withdraw from the study at any time. The subject will have the investigational device, ECG sensors, and a pulse oximetry sensor placed on them for data collection and to monitor their safety for the duration of the study. An arterial line will be placed in the radial artery, contralateral to the investigational device, under sterile conditions by a physician. To begin data collection; 10 minute periods of simultaneous invasive data from the arterial line and the non-invasive signal from the investigational device will be recorded. Once the supine recording sessions are complete, the subject will be raised to a seated position and the pressure transducer will be recalibrated. The subject will then vary both their arm positions simultaneously from heart level, to above heart level, and to below heart level to record the changes in pressure due to movement.
Once all data has been collected, the radial arterial catheter will be removed by the physician and constant pressure held on the arterial puncture for a minimum of 10 minutes. The clinician will review any final questions with the subject, the subject will be provided with phone numbers for questions pertaining to the participation in this study or research-related injury or reaction post study. Follow-up with each subject will be conducted within 5 days following participation in the study and will be conducted via telephone, text, or email.
Data Collection, Visit 2, will be divided into two phases. Phase 1 will use up to 20 subjects with the goal of collecting data for algorithm and sensor development. No requirements for certain blood pressure populations are required for Phase 1. Once the analysis of the Phase 1 results is complete, Phase 2 will use up to 30 subjects with the following requirements to test multiple blood pressure populations:
* No more than 25% will be normotensive
* At least 60% of the subjects will be hypertensive
* At least 15% of the subjects will be hypotensive
Visit 1- Screening Screening will be identical for both phases of the study. Subjects will be screened for per the inclusion criteria, assuring the subject will be a good candidate for the data collection portion of the study. If the subject does not meet the inclusion criteria they will not be invited to participate in Visit 2. During screening, the subject's wrist circumference will be recorded and measured for each arm. The clinician will perform auscultatory blood pressure measurements on both arms to determine the lateral systolic and diastolic blood pressure difference per Procedure 5.2.4.3.1. in the International Standards Organization (ISO) 81060-2:2013. Using ultrasound, the clinician will also determine if the subject has any bifurcations in the radial artery of each arm. Finally, the investigation devices will be place on both wrists of the subject to determine if adequate signal can be detected. If the subject meets all the inclusion criteria for screening they will be invited to participate in the data collection portion of the study during Visit 2.
Visit 2- Screening Visit 2, the data collection portion of the study, will begin with the volunteer test subject lying in the supine position. The subject will be reminded they may withdraw from the study at any time. The subject will have the investigational device, ECG sensors, and a pulse oximetry sensor placed on them for data collection and to monitor their safety for the duration of the study. An arterial line will be placed in the radial artery, contralateral to the investigational device, under sterile conditions by a physician. To begin data collection; 10 minute periods of simultaneous invasive data from the arterial line and the non-invasive signal from the investigational device will be recorded. Once the supine recording sessions are complete, the subject will be raised to a seated position and the pressure transducer will be recalibrated. The subject will then vary both their arm positions simultaneously from heart level, to above heart level, and to below heart level to record the changes in pressure due to movement.
Once all data has been collected, the radial arterial catheter will be removed by the physician and constant pressure held on the arterial puncture for a minimum of 10 minutes. The clinician will review any final questions with the subject, the subject will be provided with phone numbers for questions pertaining to the participation in this study or research-related injury or reaction post study. Follow-up with each subject will be conducted within 5 days following participation in the study and will be conducted via telephone, text, or email.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: