Phagenyx® System for Severe Dysphagia After Stroke

This study is looking at how well the Phagenyx® System helps people with severe dysphagia (swallowing difficulties) after a stroke. The Phagenyx® System uses Pharyngeal Electrical Stimulation (PES) to improve swallowing. Researchers will compare patients who received at least three treatments with the Phagenyx® System to a group of similar patients who received standard care without PES. The study aims to see if the Phagenyx® System improves swallowing safety and helps with nutritional management. This is an observational study, meaning researchers are watching what happens in real-world settings. They plan to include about 600 participants. To join, you must have severe dysphagia and either have received Phagenyx® treatment or require a feeding tube and dysphagia treatment. The study is currently unclear on its recruitment status.

Study design
This is an observational study comparing patients who received Pharyngeal Electrical Stimulation (PES) with the Phagenyx® System to a control group who received standard care. It is an open-label study, meaning both patients and researchers know who is receiving which treatment, and plans to include about 600 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Swallowing safety will be measured from the start of the study to about 2 days after the final PES treatment. Nutritional management will be measured from the start of the study until hospital discharge, up to about 30 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06866418

Phagenyx® Registry Study

Recruiting
Not specifiedAll AgesObservational
Phagenesis Ltd.
~600 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:1. Phagenyx® System Group Patients

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Swallowing safety
Measured over Baseline to 2 (+1 days) post final PES treatment (Approximately 6 days).
+1 more outcome measured
Dysphagia
3 sites across 3 states
Arizona1
New Jersey1
Texas1

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  • Swallowing safetyBaseline to 2 (+1 days) post final PES treatment (Approximately 6 days).

    Swallowing safety based on the change in Penetration Aspiration Scale (PAS) score from baseline (pre-PES treatment) to 2 (+1 days) post PES treatment.

  • Nutritional ManagementBaseline to Hospital Discharge (up to approximately 30 days)

    Nutritional management improvement based on the change in Functional Oral Intake Score (FOIS) from baseline (pre-PES treatment) to hospital discharge