NCT05319236

Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)

A Prospective, Multicentric Interventional Study Assessing the Range of Most Clinically Relevant Indications for Use of the Non-invasive Wireless Gabi System for the Recording, in Non-motion Condition, of SpO2, Pulse Rate, Respiratory Rate and Movements of Young Children With Underlying Medical Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Gabi SmartCare · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject. The objective of this study is to perform a first assessment of the range of most potentially clinically relevant indications for use of the Gabi system for children \< 6 years old with underlying medical conditions. This is performed by asking HCPs to review the data measured by the Gabi system after taking a medical decision independently from the Gabi data and to assess the potential clinical utility of the Gabi system. The usability of the system will also be assessed throughout questionnaires filled out by the HCPs and by the caregivers. \*During this study, the data collected by the Gabi system are not intended to be used by caregivers or HCPs to take any (medical) decisions.

Conditions

• Cardiac Disease
• Respiratory Disease
• Congenital Cardiac Defect
• Cardiovascular Diseases
• Chronic Respiratory Disease
• Chronic Cardiopulmonary Disease
• Premature Infant Disease

Interventions

Type	Name	Description
DEVICE	Gabi System	See arm description

Timeline

• Start date: 2022-02-16
• Primary completion: 2022-11-30
• Completion: 2023-06-30
• First posted: 2022-04-08
• Last updated: 2023-09-13

Locations

4 sites across 2 countries: United States, Belgium