Ignite Creation Date:
2024-07-17 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-05
Brief Title:
Vitaliti Continuous Vital Signs Monitor User-Testing Protocol VERDICT-2
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Hamilton Health Sciences Corporation
Study Overview
Official Title:
User-Testing Protocol for the Cloud DX Vitaliti Continuous Vital Signs Monitor Model CVSM-1A for Clinical Use and Self Measurement in Ambulatory Settings
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
VERDICT-2
Brief Summary:
The VERDICT-2 user testing study will user test the Cloud DX Vitaliti Continuous Vital Signs Monitor Model CVSM-1A in an ambulatory context with post-surgical participants their family members caregiver support role and clinicians nurses and physicians at Hamilton Health Sciences to examine user acceptance and user experiences while soliciting user feedback on wearability compliance and proposed clinical workflows
Detailed Description:
Effective postoperative care is faced with several challenges- patients experience major complications following surgery which often require re-hospitalization or utilization of healthcare services ie emergency room visits once discharged into the community New remote automated monitoring RAM technologies that enable data integration synthesis and real-time alerts to clinicians have the potential to transform postoperative care similar to how intraoperative care has evolved
The Cloud DX Vitaliti Continuous Vital Signs Monitor Model CVSM-1A is a continuous vital sign monitor intended to measure vital metrics including systolic and diastolic blood pressures via ECG photoplethysmography PPG pulse via PPG respiration rate via impedance respiration waveform core body temperature via infrared sensor and blood oxygen saturation levels via PPG of an adult individual using non-invasive techniques
The VERDICT-2 user testing study will user test the Cloud DX Vitaliti Continuous Vital Signs Monitor Model CVSM-1A in an ambulatory context with post-surgical participants their family members caregiver support role and clinicians nurses and physicians at Hamilton Health Sciences to examine user acceptance and user experiences while soliciting user feedback on wearability compliance and proposed clinical workflows
The Cloud DX Vitaliti Continuous Vital Signs Monitor Model CVSM-1A is a continuous vital sign monitor intended to measure vital metrics including systolic and diastolic blood pressures via ECG photoplethysmography PPG pulse via PPG respiration rate via impedance respiration waveform core body temperature via infrared sensor and blood oxygen saturation levels via PPG of an adult individual using non-invasive techniques
The VERDICT-2 user testing study will user test the Cloud DX Vitaliti Continuous Vital Signs Monitor Model CVSM-1A in an ambulatory context with post-surgical participants their family members caregiver support role and clinicians nurses and physicians at Hamilton Health Sciences to examine user acceptance and user experiences while soliciting user feedback on wearability compliance and proposed clinical workflows
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None