NCT06866418

Phagenyx® Registry Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Phagenesis Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A retrospective, open-label, matched-control registry study designed to characterize the effectiveness of Pharyngeal Electrical Stimulation (PES) to improve swallowing in patients with severe dysphagia post stroke when delivered using the Phagenyx® System in real-world clinical settings in hospitals in the United States of America (US).

Detailed description

The study will consist of a Treatment Group and a Control Group. The Treatment Group will include patients who have undergone PES treatment for severe dysphagia. The Control Group will consist of patients that qualify for PES treatment but are not treated with PES in the time period prior to implementing PES. Patients will be treated per standard of care at each institution. Each Treatment patient will receive treatment with PES in addition to other standard of care dysphagia therapies. Control subjects will receive standard of care dysphagia therapies only (no PES or other electrical stimulation therapies for dysphagia are permitted). Performance of the Phagenyx® System will be analyzed by comparing treatment outcomes for patients in the PES Group compared to patients in the Control Group. The study will include patients with severe dysphagia post stroke. The main clinical outcomes will be assessed using the participating sites' standard of care methodology and will evaluate improvements in swallowing and reduction in associated treatments and complications.

Conditions

• Dysphagia

Interventions

Type	Name	Description
DEVICE	1. Phagenyx® System Group Patients	Patients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System

Timeline

• Start date: 2025-09-15
• Primary completion: 2035-09-01
• Completion: 2036-09-01
• First posted: 2025-03-10
• Last updated: 2025-12-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study