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Prospective, Open, Non-interventional Study to Assess the Ability of an Electrical Impedance Tomograph (PlumoVista 500)

NCT04873999 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23

Last updated 2022-03-29

No results posted yet for this study

Summary

This observational PMCF study will be conducted to generate and gather clinical data from the intended target population of pediatric patients.

The intention for Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of a device throughout the device's lifecycle.

PulmoVista 500 is a lung function monitor for clinical use which continuously generates cross-sectional images of the lung function by applying the technique of electrical impedance tomography (EIT).

Conditions

  • Monitoring of Regional Distribution of Ventilation
  • Monitoring of Lung Volume

Sponsors & Collaborators

  • Drägerwerk AG & Co. KGaA

    lead INDUSTRY

Principal Investigators

  • Gerhard Wolf, PD Dr. · Children's hospital Traunstein

Eligibility

Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2021-07-28
Completion
2021-07-28

Countries

  • Germany

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 NCT04873999 on ClinicalTrials.gov