NCT03559933

PEPNS System Feasibility Study

Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) System Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Stimdia Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Mechanical ventilation is a life saving technology but can also cause damage to the lungs and diaphragm such as ventilator induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory mechanical ventilation and sedation the diaphragm begins to atrophy within as little as 18 hours. The PEPNS System consists of a console and disposable lead and will be used to stimulate the patient's diaphragm to contract in synchrony with the inspiratory cycle of the ventilator. The proprietary phrenic nerve to diaphragm stimulation (pdSTIM) Lead incorporates multipolar electrodes that align with the left and right phrenic nerves in order to stimulate the nerves to the diaphragm. This feasibility trial will investigate the safety and performance of the PEPNS System as a therapy by stimulating the diaphragm over a 48 hour period to facilitate weaning from the mechanical ventilator. The patient population includes those need to be mechanically ventilated for at least 48 hours and up to 7 days in the ICU.

Conditions

• Ventilator Induced Diaphragmatic Dysfunction (VIDD)

Interventions

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

Timeline

• Start date: 2018-07-10
• Primary completion: 2019-05-29
• Completion: 2019-05-29
• First posted: 2018-06-18
• Last updated: 2021-09-16
• Results posted: 2021-09-16

Locations

2 sites across 2 countries: Czechia, Ireland

Regulatory

• FDA-regulated device study