MedTrace Logo

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

NCT05319236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-09-13

No results posted yet for this study

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

DEVICE

Gabi System

See arm description

Sponsors & Collaborators

  • Gabi SmartCare

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-16
Primary Completion
2022-11-30
Completion
2023-06-30

Countries

  • United States
  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319236 on ClinicalTrials.gov