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The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy

NCT03840395 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-14

No results posted yet for this study

Summary

This is a prospective, multi-site, randomised, sham-controlled, single-blind (outcome assessor-blinded) study designed to assess the effects of Pharyngeal Electrical Stimulation (PES) (using Phagenyx®) for the treatment of oropharyngeal dysphagia after invasive mechanical ventilation (of any duration) by means of naso or oro-tracheal tube in critically ill intensive care unit (ICU) patients.

Conditions

Interventions

DEVICE

Pharyngeal Electrical Stimulation (PES)

The Phagenyx® system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation to the oropharynx. The Phagenyx® devices are CE labelled (2012) and will be used in accordance with their intended use label.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Cytel Inc.

    collaborator INDUSTRY

  • Phagenesis Ltd.

    lead INDUSTRY

Principal Investigators

  • Joerg Schefold, MD · University Clinic for Intensive Medicine, Inselspital, University of Bern

  • Micheal Joannidis, MD · Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I

  • Christopher Rugg, MD · Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin

  • Alois Schiefecker, MD · Medizinische Universität Innsbruck - Universitätsklinik für Neurologie

  • Stefan Kluge, MD · Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2025-08-01
Completion
2025-12-31

Countries

  • Austria
  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT03840395 on ClinicalTrials.gov