Cardiac DiseaseBRIDGENCT05319236
Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)
A study testing Gabi System in people with Cardiac Disease and Respiratory Disease, run by Gabi SmartCare at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Cardiac Disease, Respiratory Disease, Congenital Cardiac Defect
- What is being tested?
- Gabi System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 16 Feb 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Columbia University Irving Medical Center
New York, New York, 10032
Children's National Hospital
Washington D.C., District of Columbia, 20010
Belgium2 sites
Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, 2610
Clinique CHC Montlégia
Liège
About this study
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.
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.
Read more
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
- Being tested
- Gabi System
- Medical subject headings
- Heart Diseases, Respiration Disorders, Heart Defects, Congenital, Cardiovascular Diseases, Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabi SystemDevice
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Gabi System | Other | 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. Receives: Device: Gabi System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at the end of the 3-month period for each participant
Caregiver Usability
Assess the usability of the Gabi system from the point of view of the caregivers through a Usability Questionnaire.
Measured: Assessed at the end of the 3-month period for each participant
HCP Usability
Assess the usability of the Gabi system from the point of view of the HCPs through a Usability Questionnaire.
Measured: Assessed at the end of the 3-month period for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start16 Feb 2022
- Primary completion30 Nov 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gabi SmartCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319236
- Sponsor's protocol ID
- R-DND-11 BRIDGE Study_CIP
- Acronym
- BRIDGE
- Status last verified
- Feb 2023
- First submitted
- 22 Mar 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05319236
- Acronym / sponsor ID
- BRIDGE / R-DND-11 BRIDGE Study_CIP
- Conditions
- Cardiac Disease, Respiratory Disease, Congenital Cardiac Defect, Cardiovascular Diseases, Chronic Respiratory Disease, Chronic Cardiopulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Gabi SmartCareIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gabi System | Other | Device: Gabi SystemSubjects 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. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Infants and children < 6 years old.
- Subjects who present at least one of the following underlying medical conditions:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabi SystemSee arm description | Device | Gabi System |
Primary outcome
Clinical Utility
Time frame: Assessed at the end of the 3-month period for each participant
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
Time frame: Assessed at the end of the 3-month period for each participant
Assess the usability of the Gabi system from the point of view of the caregivers through a Usability Questionnaire.
HCP Usability
Time frame: Assessed at the end of the 3-month period for each participant
Assess the usability of the Gabi system from the point of view of the HCPs through a Usability Questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabi System in people with Cardiac Disease and Respiratory Disease, run by Gabi SmartCare at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Utility (time frame: Assessed at the end of the 3-month period for each participant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.