Status:
WITHDRAWN
Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line
Lead Sponsor:
SunTech Medical
Collaborating Sponsors:
Children's Hospital Los Angeles
Conditions:
Hypertension
Eligibility:
All Genders
1-3 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06172829
Start Date
November 7 2023
End Date
March 1 2024
Last Update
March 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027