Phagenyx® Registry Study
ConditionDysphagia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPhagenesis Ltd.
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 1. Phagenyx® System Group Patients
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov