Phagenyx Registry for Improving Swallowing After Stroke
Official title: Phagenyx® Registry Study: Evaluating Swallowing Therapy Outcomes and Recovery in the U.S.
Run by Phagenesis Ltd. · NCT06866418 · Data updated 2026-11-12
This registry tests whether pharyngeal electrical stimulation with the Phagenyx® System helps people with severe swallowing problems after a stroke.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Phagenesis Ltd. Industry-sponsored |
| Locations | 3 sites (Phoenix, Arizona and 2 other locations) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | September 2035 |
| Study ends | September 2036 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT06866418 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults with severe dysphagia after stroke who either received PES treatment (minimum three sessions) or met criteria for PES but did not receive it and have usable clinical records.
✕Probably not a fit
Patients with mild or non-stroke causes of dysphagia, those treated with other electrical stimulation therapies, or those lacking key outcome data are unlikely to benefit from inclusion.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a retrospective, open-label, matched-control registry comparing patients treated with Phagenyx® pharyngeal electrical stimulation (PES) to matched historical controls who did not receive PES. Treatment patients received at least three PES sessions in addition to each site's standard dysphagia care, while control patients received standard care only and no other electrical stimulation. Outcomes are drawn from participating sites' routine clinical records and focus on swallowing improvement, reductions in feeding tube use, and related complications. The study compares clinical outcomes between the PES group and control group across participating U.S. hospitals to characterize real-world performance of the device.
Why it matters
Potential benefit: If successful, PES delivered with the Phagenyx® System could speed recovery of swallowing, reduce time on feeding tubes, and lower complications such as aspiration pneumonia.
How similar studies have gone: Previous clinical studies of pharyngeal electrical stimulation have shown promising improvements in post-stroke dysphagia in some trials, though results are mixed and more real-world data are needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Phagenyx® System Group Patients: Patients underwent treatment with the Phagenyx® System for a minimum of 3 treatments. 2. Control Group Patients: Patient requires a nasogastric feeding tube for severe dysphagia and required dysphagia treatment. 3. Willing and able to provide appropriate informed consent (if required). Exclusion Criteria: 1. Primary endpoint outcome data not collected or not available. 2. In the investigator or sponsor's opinion the patient is not considered suitable. 3. Participation in another interventional study (medicinal or device) that could influence the outcomes of PES. 4. Treatment of dysphagia with other forms of electrical stimulation.
Where it's running
-
Banner University Medical Center
Phoenix, Arizona, United States Recruiting -
HMH Jersey Shore University Medical Center
Neptune City, New Jersey, United States Recruiting -
University of Texas
Houston, Texas, United States Recruiting
Study contacts
- Study coordinator: Jennifer Miller
- Email: jennifer.miller@phagenesis.com
- Phone: 248-420-3292
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.