Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line

Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line Against Invasive Intra-arterial Reference According to the ANSI/AAMI/ISO 810602-2019 Protocol for Neonates, Infants, Children

NCT06172829•SunTech Medical

View on ClinicalTrials.gov

Summary

Patients will be selected according to specific criteria. Upon selection, patients with an existing intra-arterial line will have their blood pressure monitored with the SunTech Advantage MX module in addition to the reference data collected from intra-arterial line. Data collected from the Advantage MX module will be compared to the reference data from the intra-arterial line.

Eligibility

Age

0 - 3 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•At least 3 subjects shall be \< 1,000g in weight.
•At least 3 subjects shall be 1,000g to 2,000g in weight.
•At least 3 subjects shall be \>2,000g
•At least 3 subjects shall be ≥ 29 days and \< 1 year of age.
•At least 3 subjects shall be ≥ 1 year and \< 3 years of age.

Exclusion Criteria

•Subjects who study personnel determine invasive blood pressure measurements will be unreliable
•Patients found to have a-fib, irregular heart rhythm, dysrhythmias, bigeminy, trigeminy, and isolated premature ventricular beats (VPBs) during the enrollment process are to be ineligibile to participate in the study
•Patients who are prescribed anti-coagulation medication during the enrollment process or begin anti-coagulation medication after enrollment are ineligible to participate in the study.

Locations (1)

Children's Hospital of Los Angeles

Los Angeles, California, United States

Key Dates

Start Date

November 7, 2023

Primary Completion Date

March 1, 2024

Completion Date

March 1, 2024

Last Updated

March 5, 2024

Conditions

Hypertension

Interventions

Advantage MX Module

DEVICE

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication

Penn Medicine Healthy Heart

Preliminary Human Trials of F230 Tablets