Phagenyx® Registry Study (RESTORE-US)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Device: 1. Phagenyx® System Group Patients

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Jennifer Miller; Phone Number: 248-420-3292; Email: jennifer.miller@phagenesis.com

Study Locations

• United States
  • New Jersey
    • Neptune City, New Jersey, United States, 07753
      • Recruiting
      • HMH Jersey Shore University Medical Center
      • Principal Investigator: Sanskriti Mishra, MD
      • Contact: Alexandria Nwar; Phone Number: 732-776-3681; Email: alexandria.nuwar@hmhn.org
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas
      • Contact: Elena Moreno; Phone Number: 713-500-5638; Email: Elena.Espino@uth.tmc.edu
      • Principal Investigator: Alex Choi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Up to 600 patients total, comprised of 300 evaluable adult patients with severe dysphagia post stroke will be treated with PES with an additional 300 subjects enrolled as historical controls.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; Patient requires a nasogastric feeding tube for severe dysphagia and required dysphagia treatment
Treatment Group; Patients who have undergone PES treatment for severe dysphagia.	Device: 1. Phagenyx® System Group Patients; Patients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing safety	Swallowing safety based on the change in Penetration Aspiration Scale (PAS) score from baseline (pre-PES treatment) to 2 (+1 days) post PES treatment.	Baseline to 2 (+1 days) post final PES treatment (Approximately 6 days).
Nutritional Management	Nutritional management improvement based on the change in Functional Oral Intake Score (FOIS) from baseline (pre-PES treatment) to hospital discharge	Baseline to Hospital Discharge (up to approximately 30 days)

Collaborators and Investigators

• Sponsor: Phagenesis Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): September 1, 2035
• Study Completion (Estimated): September 1, 2036

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: AHE-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No