Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560034
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements
Sponsor:
None
Organization:
None
Study Overview
Official Title:
VicorderCS NIBP Validation Study to Assess Its Ability to Capture Blood Pressure Measurements
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
80 Beats Medical introduces the VicorderCS the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks This advanced diagnostic equipment offers non-invasive collection and computation of a plethora of cardiovascular markers It is faster easier to use and more portable than its predecessor with enhanced connectivity options for extended marker collection and analysis These markers enable early diagnosis of cardiovascular disease ensuring positive patient outcomes With a strong foundation in numerous published clinical studies the VicorderCS enhances data collection and analysis capabilities empowering the research community in developing new drugs and therapeutics This validation study is purposed to evaluate one of the physiological parameters that is measured by the VicorderCS system which is Non-invasive Blood Pressure NIBP via the common oscillometric cuff-based method
Detailed Description:
The VicorderCS will enable medical personnel to conduct Blood Pressure measurement procedures for the evaluation of a participants cardiovascular health
Clinical Rationale This study will compare the accuracy of the 80 Beats Medical noninvasive blood pressure measurement using the VicorderCS device with that of human observers readings using the auscultatory method as required by the applicable ISO standard Non-invasive sphygmomanometers part 2 - clinical investigation of intermittent automated measurement type1 The study will aim to enroll 120 participants for blood pressure readings using both the VicorderCS and auscultatory method using a calibrated aneroid sphygmomanometer
Design Rationale The VicorderCS blood pressure study will be conducted using consenting participants in Summit County Colorado and designed to be compliant with the requirements within the applicable ISO standard1 Study data including systolic and diastolic blood pressure readings will be collected using both the VicorderCS and auscultatory method using a sphygmo-manometer
Proposed Solution 80 Beats Medical has developed the VicorderCS which is indicated for the non-invasive measurement of blood pressure to detect cardiovascular health risks
Device Description
VicorderCS consists of the following components
1 Vascular Sensor VCS-VAS-1000 measurement device used with accessories cuffs and tubes connected to the device
2 Data Station VCS-DAT-1000 for data collection and analysis
Platform Data Privacy and Security The VicorderCS application follows industry best practices for data privacy and security including compliance with applicable laws and regulations such as the General Data Protection Regulation GDPR and the Health Insurance Portability and Accountability Act HIPAA 80 Beats Medical has implemented technical and organizational measures to safeguard user data against unauthorized access disclosure alteration or destruction and regularly conducts security audits and risk assessments to identify and mitigate potential threats
80 Beats Medical has established policies and procedures to ensure that user data is used only for its intended purpose and is not shared with unauthorized parties
There are two data sets that will be recorded during this study One is the pressure waveforms on all four limbs and the other is the Systolic and Diastolic blood pressure measurement on the left arm All data on the vascular sensor will be deleted after the test is complete However the pressure waveforms will be uploaded to the data station before being deleted This will be part of an internal data pool for use in perpetuity
Users are provided with transparency and control over their data including the ability to access correct and delete their information Users can opt out of data collection and sharing where applicable Security and privacy of user data are critical to maintaining user trust and 80 Beats Medical is committed to ensuring the application meets the highest standards for data privacy and security
STUDY OBJECTIVES Primary Objective The objective of this study is to collect blood pressure readings using the VicorderCS device We will subsequently conduct statistical analysis by comparing to the traditional sphygmomanometer method according to the ISO standard
Secondary Objectives A secondary objective of this study is to collect raw waveform data on the opposite arm and both ankles in order to optimize analysis capabilities in the future
INVESTIGATIONAL PLAN General Schema of Study Design In this cross-sectional study we will look at the systolic Sys and diastolic Dia blood pressure of 120 subjects ages 18 years or older
The primary hypothesis of this study is that the VicorderCS can detect and analyze blood pressure in an easy-to-use and portable device providing more complete diagnostics at the point of care
Study Device 80 Beats Medical has developed the VicorderCSCS which is indicated for the non-invasive measurement of blood pressure
Indications for use The VicorderCS Device is indicated for adult patients needing a blood pressure reading
Clinical Rationale This study will compare the accuracy of the 80 Beats Medical noninvasive blood pressure measurement using the VicorderCS device with that of human observers readings using the auscultatory method as required by the applicable ISO standard Non-invasive sphygmomanometers part 2 - clinical investigation of intermittent automated measurement type1 The study will aim to enroll 120 participants for blood pressure readings using both the VicorderCS and auscultatory method using a calibrated aneroid sphygmomanometer
Design Rationale The VicorderCS blood pressure study will be conducted using consenting participants in Summit County Colorado and designed to be compliant with the requirements within the applicable ISO standard1 Study data including systolic and diastolic blood pressure readings will be collected using both the VicorderCS and auscultatory method using a sphygmo-manometer
Proposed Solution 80 Beats Medical has developed the VicorderCS which is indicated for the non-invasive measurement of blood pressure to detect cardiovascular health risks
Device Description
VicorderCS consists of the following components
1 Vascular Sensor VCS-VAS-1000 measurement device used with accessories cuffs and tubes connected to the device
2 Data Station VCS-DAT-1000 for data collection and analysis
Platform Data Privacy and Security The VicorderCS application follows industry best practices for data privacy and security including compliance with applicable laws and regulations such as the General Data Protection Regulation GDPR and the Health Insurance Portability and Accountability Act HIPAA 80 Beats Medical has implemented technical and organizational measures to safeguard user data against unauthorized access disclosure alteration or destruction and regularly conducts security audits and risk assessments to identify and mitigate potential threats
80 Beats Medical has established policies and procedures to ensure that user data is used only for its intended purpose and is not shared with unauthorized parties
There are two data sets that will be recorded during this study One is the pressure waveforms on all four limbs and the other is the Systolic and Diastolic blood pressure measurement on the left arm All data on the vascular sensor will be deleted after the test is complete However the pressure waveforms will be uploaded to the data station before being deleted This will be part of an internal data pool for use in perpetuity
Users are provided with transparency and control over their data including the ability to access correct and delete their information Users can opt out of data collection and sharing where applicable Security and privacy of user data are critical to maintaining user trust and 80 Beats Medical is committed to ensuring the application meets the highest standards for data privacy and security
STUDY OBJECTIVES Primary Objective The objective of this study is to collect blood pressure readings using the VicorderCS device We will subsequently conduct statistical analysis by comparing to the traditional sphygmomanometer method according to the ISO standard
Secondary Objectives A secondary objective of this study is to collect raw waveform data on the opposite arm and both ankles in order to optimize analysis capabilities in the future
INVESTIGATIONAL PLAN General Schema of Study Design In this cross-sectional study we will look at the systolic Sys and diastolic Dia blood pressure of 120 subjects ages 18 years or older
The primary hypothesis of this study is that the VicorderCS can detect and analyze blood pressure in an easy-to-use and portable device providing more complete diagnostics at the point of care
Study Device 80 Beats Medical has developed the VicorderCSCS which is indicated for the non-invasive measurement of blood pressure
Indications for use The VicorderCS Device is indicated for adult patients needing a blood pressure reading
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None