RecruitingNCT06866418

Phagenyx® Registry Study

Phagenyx® Registry Study: Evaluating Swallowing Therapy Outcomes and Recovery in the U.S.


Sponsor

Phagenesis Ltd.

Enrollment

600 participants

Start Date

Sep 15, 2025

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria3

  • 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).

Exclusion Criteria4

  • 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.

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Interventions

DEVICE1. Phagenyx® System Group Patients

Patients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System


Locations(2)

HMH Jersey Shore University Medical Center

Neptune City, New Jersey, United States

University of Texas

Houston, Texas, United States

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NCT06866418


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