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

Primary Purpose

Cardiac Disease, Respiratory Disease, Congenital Cardiac Defect

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Gabi System
Sponsored by
Gabi SmartCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Disease

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Infants and children < 6 years old.

  2. Subjects who present at least one of the following underlying medical conditions:

    1. Subjects who underwent a congenital cardiac or cardiopulmonary surgery recently and could benefit from an additional post-surgery monitoring at home, per the investigator's opinion.
    2. Subjects at risk awaiting surgery.
    3. Subjects hospitalized following a severe respiratory condition within the past 2 weeks requiring invasive or non-invasive ventilation or oxygen therapy.
    4. Subjects hospitalized following a severe cardiovascular condition within the past 2 weeks, including severe heart failure, tachycardia or bradycardia.
    5. Subjects with chronic respiratory disease, such as asthma, developmental or cardiovascular conditions who could benefit from medical monitoring at home, per the investigator's opinion.
    6. Subjects with chronic respiratory support at home.
    7. Premature babies who required intensive neonatal care.
    8. Subjects hospitalized following a Brief Resolved Unexpected Event (BRUE) within the past 2 weeks.
    9. A clinical risk identified by the investigator which justifies the potential benefit of having a Gabi system used by the subject
  3. Subject is (or is willing to be) followed up by an HCP of the investigation site during the duration of the study.
  4. Signed informed consent form prior to performing any study specific procedure.
  5. Willing and likely (based on the investigator's judgement) to comply with all study requirements.

Exclusion Criteria:

  1. Weight < 2.5 kg.
  2. Subject presenting an anatomical limitation that would prevent the use of the Gabi system.
  3. Subjects presenting a motor disorder that would prevent the use of the Gabi system (with the exception of epilepsy ).
  4. Subjects participating in another interventional clinical study (with the exception of registries), which may have an impact on this study outcomes, based on the investigator's judgement.

Sites / Locations

  • Children's National Hospital
  • Columbia University Irving Medical Center
  • Universitair Ziekenhuis Antwerpen (UZA)
  • Clinique CHC Montlégia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Gabi System

Arm Description

Subjects will wear the Gabi system each time they go to sleep or are resting, to measure and record their SpO2, pulse rate, respiratory rate and movements.

Outcomes

Primary Outcome Measures

Clinical Utility
Define the range of most potentially clinically significant indications for use of the Gabi system based on the Gabi system clinical utility assessment per medical condition, assessed throughout Medical Decision Questionnaires and Clinical Utility Questionnaires.
Caregiver Usability
Assess the usability of the Gabi system from the point of view of the caregivers through a Usability Questionnaire.
HCP Usability
Assess the usability of the Gabi system from the point of view of the HCPs through a Usability Questionnaire.

Secondary Outcome Measures

Full Information

First Posted
March 22, 2022
Last Updated
September 11, 2023
Sponsor
Gabi SmartCare
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1. Study Identification

Unique Protocol Identification Number
NCT05319236
Brief Title
Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)
Acronym
BRIDGE
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gabi SmartCare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Respiratory Disease, Congenital Cardiac Defect, Cardiovascular Diseases, Chronic Respiratory Disease, Chronic Cardiopulmonary Disease, Premature Infant Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gabi System
Arm Type
Other
Arm Description
Subjects will wear the Gabi system each time they go to sleep or are resting, to measure and record their SpO2, pulse rate, respiratory rate and movements.
Intervention Type
Device
Intervention Name(s)
Gabi System
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Clinical Utility
Description
Define the range of most potentially clinically significant indications for use of the Gabi system based on the Gabi system clinical utility assessment per medical condition, assessed throughout Medical Decision Questionnaires and Clinical Utility Questionnaires.
Time Frame
Assessed at the end of the 3-month period for each participant
Title
Caregiver Usability
Description
Assess the usability of the Gabi system from the point of view of the caregivers through a Usability Questionnaire.
Time Frame
Assessed at the end of the 3-month period for each participant
Title
HCP Usability
Description
Assess the usability of the Gabi system from the point of view of the HCPs through a Usability Questionnaire.
Time Frame
Assessed at the end of the 3-month period for each participant

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infants and children < 6 years old. Subjects who present at least one of the following underlying medical conditions: Subjects who underwent a congenital cardiac or cardiopulmonary surgery recently and could benefit from an additional post-surgery monitoring at home, per the investigator's opinion. Subjects at risk awaiting surgery. Subjects hospitalized following a severe respiratory condition within the past 2 weeks requiring invasive or non-invasive ventilation or oxygen therapy. Subjects hospitalized following a severe cardiovascular condition within the past 2 weeks, including severe heart failure, tachycardia or bradycardia. Subjects with chronic respiratory disease, such as asthma, developmental or cardiovascular conditions who could benefit from medical monitoring at home, per the investigator's opinion. Subjects with chronic respiratory support at home. Premature babies who required intensive neonatal care. Subjects hospitalized following a Brief Resolved Unexpected Event (BRUE) within the past 2 weeks. A clinical risk identified by the investigator which justifies the potential benefit of having a Gabi system used by the subject Subject is (or is willing to be) followed up by an HCP of the investigation site during the duration of the study. Signed informed consent form prior to performing any study specific procedure. Willing and likely (based on the investigator's judgement) to comply with all study requirements. Exclusion Criteria: Weight < 2.5 kg. Subject presenting an anatomical limitation that would prevent the use of the Gabi system. Subjects presenting a motor disorder that would prevent the use of the Gabi system (with the exception of epilepsy ). Subjects participating in another interventional clinical study (with the exception of registries), which may have an impact on this study outcomes, based on the investigator's judgement.
Facility Information:
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Universitair Ziekenhuis Antwerpen (UZA)
City
Antwerp
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Clinique CHC Montlégia
City
Liège
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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