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The Intrepid Clinical Engineering Study

NCT05636332 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-25

Study results available
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Summary

The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.

Conditions

  • Sudden Cardiac Arrest

Interventions

DIAGNOSTIC_TEST

12 lead Electrocardiogram

12 lead Electrocardiogram

Sponsors & Collaborators

  • Philips Clinical & Medical Affairs Global

    lead INDUSTRY

Principal Investigators

  • Alaa El-Gendy, MD, MSc, FCCP · Lehigh Pulmonary Associates, PA (D/B/A Florida Lung & Sleep Associates)

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
29 Days
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2022-11-02
Completion
2022-11-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05636332 on ClinicalTrials.gov