Cardiovascular Diseases Clinical Trial
— BRIDGEOfficial 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.
Verified date | February 2023 |
Source | Gabi SmartCare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | June 30, 2023 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 5 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Antwerpen (UZA) | Antwerp | |
Belgium | Clinique CHC Montlégia | Liège | |
United States | Columbia University Irving Medical Center | New York | New York |
United States | Children's National Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Gabi SmartCare |
United States, Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Assessed at the end of the 3-month period for each participant | |
Primary | Caregiver Usability | Assess the usability of the Gabi system from the point of view of the caregivers through a Usability Questionnaire. | Assessed at the end of the 3-month period for each participant | |
Primary | HCP Usability | Assess the usability of the Gabi system from the point of view of the HCPs through a Usability Questionnaire. | Assessed at the end of the 3-month period for each participant |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|