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

Withdrawn

• Conditions: Hypertension
• Interventions: Device: Advantage MX Module

• Registration Number: NCT06172829
• Lead Sponsor: SunTech Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-07
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-15
• Status Verified: 2024-03
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
At least 3 subjects shall be >/= 29 days and < 1 year of age	Advantage MX Module	-
At least 3 subjects shall be 1,000g to 2,000g in weight	Advantage MX Module	-
At least 3 subjects shall be >2,000g	Advantage MX Module	-
At least 3 subjects shall be <1,000g in weight	Advantage MX Module	-
At least 3 subjects shall be >/= 1 year and <3 years of age	Advantage MX Module	-

Primary Outcome Measures

Name	Time	Method
The blood pressure measurement	approximately 1 hour	collected from the Advantage MX module matches the intra-arterial line data

Trial Locations

Locations (1)

Children's Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States