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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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06172829
Enrollment
0
Registered
2023-12-15
Start date
2023-11-07
Completion date
2024-03-01
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief 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.

Interventions

DEVICEAdvantage MX Module

no intervention will be provided.

Sponsors

Children's Hospital Los Angeles
CollaboratorOTHER
SunTech Medical
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 3 Years
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. * Exclusions can also occur post-data review based on

Design outcomes

Primary

MeasureTime frameDescription
The blood pressure measurementapproximately 1 hourcollected from the Advantage MX module matches the intra-arterial line data

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026