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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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.

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
Gabi SmartCare

3 total trials

What the finished NCT05319236 record still lists

NCT05319236 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower).

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 a single indexed study location in 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.

Similar trials for Cardiovascular Diseases

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05319236's enrollment target sits among peer trials

101 193rd of 300 higher than 108 of 300 other Cardiovascular Diseases trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05319236, the US trial registry maintained by the National Library of Medicine. NCT05319236 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.