Phagenyx® Registry Study: Evaluating Swallowing Therapy Outcomes and Recovery in the U.S.
Phagenesis Ltd.
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).
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 stimulat…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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 inf…
Interventions
- Device1. Phagenyx® System Group Patients
Patients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System
Locations (2)
- HMH Jersey Shore University Medical CenterNeptune City, New Jersey
- University of TexasHouston, Texas