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Pilot Study of TransAeris® System in Surgical Patients at Risk of Prolonged Mechanical Ventilation

NCT04309123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-08

No results posted yet for this study

Summary

This study will be conducted as a pilot trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged mechanical ventilation (PMV).

Conditions

  • Ventilator-Induced Diaphragm Dysfunction

Interventions

DEVICE

TransAeris System

The TransAeris System is a temporary percutaneous intramuscular diaphragm stimulator intended for patients at risk of or on prolonged positive pressure mechanical ventilation. TransAeris is indicated for use in the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD).

Sponsors & Collaborators

  • Synapse Biomedical

    lead INDUSTRY

Principal Investigators

  • Raymond P Onders, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-30
Primary Completion
2021-03-31
Completion
2021-04-01
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 NCT04309123 on ClinicalTrials.gov