Phagenyx® Registry Study
RESTORE-US
1 other identifier
observational
600
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedStudy Start
First participant enrolled
September 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2036
December 22, 2025
December 1, 2025
10 years
March 4, 2025
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (2)
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.
Interventions
Patients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Phagenesis Ltd.lead
Study Sites (2)
HMH Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
University of Texas
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2025
First Posted
March 10, 2025
Study Start
September 15, 2025
Primary Completion (Estimated)
September 1, 2035
Study Completion (Estimated)
September 1, 2036
Last Updated
December 22, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share