Phagenyx® Registry Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 1. Phagenyx® System Group Patients.
- Who it may be relevant to
- Registry conditions: Dysphagia. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phagenyx® Registry Study: Evaluating Swallowing Therapy Outcomes and Recovery in the U.S.
Overview
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.
Interventions
- Device 1. Phagenyx® System Group Patients
Patients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System
Primary outcome measures
- Swallowing safety [Time frame: Baseline to 2 (+1 days) post final PES treatment (Approximately 6 days).]
- Nutritional Management [Time frame: Baseline to Hospital Discharge (up to approximately 30 days)]
Eligibility criteria
Inclusion criteria
- Phagenyx® System Group Patients: Patients underwent treatment with the Phagenyx® System for a minimum of 3 treatments.
- Control Group Patients: Patient requires a nasogastric feeding tube for severe dysphagia and required dysphagia treatment.
- Willing and able to provide appropriate informed consent (if required).
Exclusion criteria
- Primary endpoint outcome data not collected or not available.
- In the investigator or sponsor's opinion the patient is not considered suitable.
- Participation in another interventional study (medicinal or device) that could influence the outcomes of PES.
- Treatment of dysphagia with other forms of electrical stimulation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Banner University Medical Center — Phoenix
- HMH Jersey Shore University Medical Center — Neptune City
- University of Texas — Houston
Identifiers
NCT: NCT06866418 · AHE-07