CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
PEPNS Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03559933
NCT03559933N/ACompleted

Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) System Feasibility Study

Stimdia Medical Inc.·interventional·Posted Jun 18, 2018·Updated Sep 16, 2021

In Brief

A clinical study evaluating PEPNS System for Ventilator Induced Diaphragmatic Dysfunction (VIDD). Completed, enrolled 12 participants across 2 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Ireland
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 18, 2018
Enrollment StartJul 10, 2018
Primary CompletionMay 29, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.0 years ago

Interventions

PEPNS Systemdevice

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