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.
Phagenyx® Registry Study
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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What this trial measures
- 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