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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1. Phagenyx® System Group Patients | Device | Patients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Miller | Contact | 248-420-3292 | jennifer.miller@phagenesis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Recruiting | Phoenix | Arizona | 85006 | United States |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| HMH Jersey Shore University Medical Center | Recruiting | Neptune City | New Jersey | 07753 | United States |
|
| University of Texas | Recruiting | Houston | Texas | 77030 | United States |
|
| D010038 | Otorhinolaryngologic Diseases |