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PEPNS System Feasibility Study

NCT03559933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-09-16

Study results available
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Summary

The purpose of this feasibility study is to evaluate the safety and performance of the PEPNS System in patients that need to be mechanically ventilated for at least 48 hours and up to 7 days in the Intensive Care Unit (ICU).

Conditions

  • Ventilator Induced Diaphragmatic Dysfunction (VIDD)

Interventions

DEVICE

PEPNS System

PEPNS System therapy will be delivered periodically up to 48 hours or less if patient is no longer being mechanically ventilated.

Sponsors & Collaborators

  • Stimdia Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Michal M Soták, MD · Military University Hospital (UVN) Prague

  • James O'Rourke, PhD · Beaumont Hospital Dublin, Ireland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2019-05-29
Completion
2019-05-29
FDA Device
Yes

Countries

  • Czechia
  • Ireland

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 NCT03559933 on ClinicalTrials.gov