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NCT06172829 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT06172829
Other study ID # Advantage MX Neonate-Infant
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 7, 2023
Est. completion date March 1, 2024

Study information
Verified date March 2024
Source SunTech Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 3 Years
Eligibility 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. - Exclusions can also occur post-data review based on exclusion criteria according to ANSI/AAMI/ISO 81060-2:2019

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Advantage MX Module
no intervention will be provided.

Locations
Country Name City State
United States Children's Hospital of Los Angeles Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
SunTech Medical Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The blood pressure measurement collected from the Advantage MX module matches the intra-arterial line data approximately 1 hour
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