Phagenyx Registry for Improving Swallowing After Stroke

Phagenyx® Registry Study: Evaluating Swallowing Therapy Outcomes and Recovery in the U.S.

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
• Enrollment: 600 (estimated)
• Sex: All
• Sponsor: Phagenesis Ltd. (industry)
• Locations: 2 sites (Neptune City, New Jersey and 1 other locations)
• Trial ID: NCT06866418 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Neptune City, New Jersey and 1 other locations

• 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

Conditions: Dysphagia