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COMPLETED NA

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

NCT05319236 · View on ClinicalTrials.gov ↗

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

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05319236

The ClinicalTrials.gov registry entry for NCT05319236 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gabi SmartCare, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05319236 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Other, District of Columbia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05319236?

The interventions under investigation include: Gabi System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05319236?

This trial is sponsored by Gabi SmartCare, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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