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

March 1, 2024 updated by: SunTech Medical

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital of Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study is only accepting neonate and pediatric patients who meet the inclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
At least 3 subjects shall be <1,000g in weight
Device: Advantage MX Module
no intervention will be provided.
At least 3 subjects shall be 1,000g to 2,000g in weight
Device: Advantage MX Module
no intervention will be provided.
At least 3 subjects shall be >2,000g
Device: Advantage MX Module
no intervention will be provided.
At least 3 subjects shall be >/= 29 days and < 1 year of age
Device: Advantage MX Module
no intervention will be provided.
At least 3 subjects shall be >/= 1 year and <3 years of age
Device: Advantage MX Module
no intervention will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The blood pressure measurement
Time Frame: approximately 1 hour
collected from the Advantage MX module matches the intra-arterial line data
approximately 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SunTech Medical

Collaborators

Children's Hospital Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Advantage MX Neonate-Infant

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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