Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT06866418
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phagenyx® Registry Study
Sponsor:
Phagenesis Ltd.
Organization:
Study Overview
Official Title:
Phagenyx® Registry Study: Evaluating Swallowing Therapy Outcomes and Recovery in the U.S.
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTORE-US
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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: