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Recruiting
NCT06866418
Phagenyx® Registry Study
Conditions: Dysphagia
Sex: All
Healthy volunteers: No
Enrollment: 600
Sponsor: Phagenesis Ltd.
Location: Banner University Medical Center Phoenix Arizona
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).
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06866418). StuddyBuddy aggregates publicly available trial information.