Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-01-03 @ 5:57 PM
Study NCT ID:
NCT06682312
Status:
TERMINATED
Last Update Posted:
2024-11-12
First Post:
2024-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Philips Non-Invasive Blood Pressure Validation Study
Sponsor:
Philips Clinical & Medical Affairs Global
Organization:
Study Overview
Official Title:
Element Boulder Clinical Investigation Plan Philips Non-Invasive Blood Pressure Validation Study
Status:
TERMINATED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol violations resulting in wrong stratification requirements
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to provide supporting documentation of the blood pressure performance for the Philips EarlyVue VS30 monitor on the intended adult and pediatric population. The same arm sequential method with dual observer auscultation will be used to collect data.
Detailed Description:
The Philips EarlyVue VS30 monitor, and approved Philips Gentle Care cuffs will be evaluated in comparison to dual reference auscultation. The study will consist of a minimum of 85 participants, specifically, 35 children aged 3-12 years and 50 participants older than 12 years. The participants enrolled will approximate the distribution of blood pressures and biceps circumferences as outlined in ISO 81060-2:2018/AMD 2:2024. The maximum number of participants enrolled will not exceed 170 participants.
Blood pressure measurements will follow ISO 81060-2:2018/AMD 2:2024, Section 5.2.4.1 Same arm sequential method.
Two trained observers, typically a Registered Nurse (RN), Licensed Practical Nurse (LPN), or Respiratory Therapist (RT) will observe (listen to) the Korotkoff sounds at the artery at the site of cuff placement. The reference blood pressure measurements observed by the auscultators will be performed sequentially with the device under test. The auscultators will complete 1 or 2 initial baseline auscultatory reference blood pressure measurements and device under test measurements. This is followed by 3 to 8 paired blood pressure readings of auscultatory reference blood pressure measurements alternated with device under test measurements. All participants must contribute 3 valid paired data points requiring three DUT readings paired with three reference blood pressure readings. The reference blood pressure readings for analysis will be the average of the reference dual auscultation values before and after DUT reading.
The data included for the final analysis will contain no fewer than 35 participants aged 3-12 years, and no fewer than 50 participants over the age of 12 and a minimum of 255 valid paired observations.
Blood pressure measurements will follow ISO 81060-2:2018/AMD 2:2024, Section 5.2.4.1 Same arm sequential method.
Two trained observers, typically a Registered Nurse (RN), Licensed Practical Nurse (LPN), or Respiratory Therapist (RT) will observe (listen to) the Korotkoff sounds at the artery at the site of cuff placement. The reference blood pressure measurements observed by the auscultators will be performed sequentially with the device under test. The auscultators will complete 1 or 2 initial baseline auscultatory reference blood pressure measurements and device under test measurements. This is followed by 3 to 8 paired blood pressure readings of auscultatory reference blood pressure measurements alternated with device under test measurements. All participants must contribute 3 valid paired data points requiring three DUT readings paired with three reference blood pressure readings. The reference blood pressure readings for analysis will be the average of the reference dual auscultation values before and after DUT reading.
The data included for the final analysis will contain no fewer than 35 participants aged 3-12 years, and no fewer than 50 participants over the age of 12 and a minimum of 255 valid paired observations.
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?:
False
Is an FDA AA801 Violation?: