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Study of TransAeris® System for Enhanced Recovery After Surgery in France

NCT05404477 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-12

No results posted yet for this study

Summary

This study will be conducted as a randomized 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 includes four TransLoc® intramuscular diaphragm electrodes, the TransAeris external stimulator, and the FrictionLoc® connectors which provide the interface between the TransLoc electrodes and the TransAeris stimulator.

Sponsors & Collaborators

  • Synapse Biomedical

    lead INDUSTRY

Principal Investigators

  • Charles-Henri David · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-22
Primary Completion
2023-07-13
Completion
2023-08-17
FDA Device
Yes

Countries

  • France

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 NCT05404477 on ClinicalTrials.gov