RECRUITING

ModPG3 Neo-Infant ISO 81060

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today. Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases. SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation. The purpose of this study is to test the algorithms contained in the ModPG3 on Neonate and Infants subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

Official Title

ModPG3 Neonate and Infant AAMI (Association for the Advancement of Medical Instrumentation) 2018 ISO Clinical Investigation Protocol of SureBP and StepBP Algorithms

Quick Facts

Study Start:2024-02-23
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05976425

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.

Ages Eligible for Study:Not specified to 3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Baxter Clinical Trials Disclosure Call Center
CONTACT
(224) 948-7359
Global_CORP_ClinicalTrialsDisclosure@baxter.com

Study Locations (Sites)

East Carolina University
Greenville, North Carolina, 27834
United States

Collaborators and Investigators

Sponsor: Baxter Healthcare Corporation

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 Registration Dates

Study Start Date2024-02-23
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-02-23
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Blood Pressure