Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-30 @ 12:57 AM
Study NCT ID:
NCT05105204
Status:
UNKNOWN
Last Update Posted:
2021-11-03
First Post:
2021-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ArteVu Blood Pressure Accuracy Study
Sponsor:
Cardio Ring Technologies, Inc. Taiwan Branch
Organization:
Study Overview
Official Title:
ArteVu Blood Pressure Accuracy Study
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
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:
ARTEVU
Brief Summary:
A continuous noninvasive blood pressure monitoring digital fingertip clip device, the ArteVu, will be compared against the reference arterial catheter during operation. The device safety and its blood pressure accuracy will be examined in the study.
Detailed Description:
ArteVu is a non-invasive and continuous blood pressure monitor. It detects the arterial pressure waveform with a force sensor that detects the arterial pulsation that produces changes in pressure transmitted through the subcutaneous tissue overlying or adjacent to the digital arteries. The data is transmitted to a parameter module to display noninvasive and continuous blood pressure in a hospital setting. The primary objective of this study is to validate ArteVu's blood pressure and heart rate measurement accuracy by comparing its values simultaneously with the corresponding values obtained from an invasive radial arterial line. The secondary objective is to evaluate the effectiveness of utilizing ArteVu for continuous blood pressure measurements. The study population includes 50 patients undergoing surgery who requires general anesthesia and continuous blood pressure measurement with a radial arterial line. Blood pressure values measured from the arterial line will be recorded simultaneously during ArteVu's measurements.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: