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
This trial does not accept healthy volunteersQualifiers
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 population
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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
1. Phagenyx® System Group Patients
DevicePatients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Control Group0 interventions
Group B: Treatment Group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 2 (+1 days) post final PES treatment (Approximately 6 days).2
Nutritional Management
Nutritional management improvement based on the change in Functional Oral Intake Score (FOIS) from baseline (pre-PES treatment) to hospital discharge
Time frame
Baseline to Hospital Discharge (up to approximately 30 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov