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NCT05319236 · ClinicalTrials.gov registry record · NA

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

A NA study of Cardiovascular Diseases and Cardiac Disease, sponsored by Gabi SmartCare.

Completed
Registry status
NA
Development phase
101
Enrollment target
4
Study locations

NCT05319236 is a NA study of Cardiovascular Diseases and Cardiac Disease that has completed, run by Gabi SmartCare. The registered enrollment target is 101 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT05319236, a NA study of Cardiovascular Diseases and Cardiac Disease, has completed, sponsored by Gabi SmartCare.

COMPLETED
Registry status
NA
Development phase
101 participants
Enrollment target
4
Study locations

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.

Interventions

  • DEVICE Gabi System

Study Locations (4)

Other

  • Universitair Ziekenhuis Antwerpen (UZA) - Antwerp
  • Clinique CHC Montlégia - Liège

District of Columbia

  • Children's National Hospital - Washington D.C.

New York

  • Columbia University Irving Medical Center - New York

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2022-02-16
Est. Completion 2023-06-30
Phase NA

Sponsor

Gabi SmartCare

3 total trials

What the Registry Record Tells You About NCT05319236

The ClinicalTrials.gov registry entry for NCT05319236 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The listed sponsor is Gabi SmartCare, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 7 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Gabi System is the first listed.

NCT05319236 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Other, District of Columbia, New York.

Frequently Asked Questions

What is clinical trial NCT05319236 about?

NCT05319236 is a clinical study titled "Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)". 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 potentia...

What is the current status of trial NCT05319236?

This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2022-02-16. Estimated completion is 2023-06-30.

What conditions does trial NCT05319236 study?

This clinical trial studies the following conditions: Cardiovascular Diseases, Cardiac Disease, Respiratory Disease, Chronic Respiratory Disease, Premature Infant Disease.

What interventions are being tested in trial NCT05319236?

The interventions under investigation include: Gabi System (DEVICE).

Who is sponsoring clinical trial NCT05319236?

This trial is sponsored by Gabi SmartCare, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05319236 being conducted?

This trial has 4 study locations across District of Columbia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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