Phagenyx® Registry Study

Part of paid clinical trials in Neptune City, New Jersey.

Sponsor
Phagenesis Ltd.
Study ID
NCT06866418
Status
Recruiting
Apply to this trial

Conditions

  • Dysphagia

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1. Phagenyx® System Group Patients — DEVICE
    Patients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System

Study Details

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).

Key Dates

Start date
Sep 15, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2035
Completion
Sep 30, 2036

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Control Group
    Patient requires a nasogastric feeding tube for severe dysphagia and required dysphagia treatment
  • Arm: Treatment Group
    Patients who have undergone PES treatment for severe dysphagia.

Primary Outcome Measure

Swallowing safety [ Time Frame: Baseline to 2 (+1 days) post final PES treatment (Approximately 6 days). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
HMH Jersey Shore University Medical CenterNeptune CityNew Jersey07753
Alexandria Nwar
[email protected]
732-776-3681
Sanskriti Mishra, MD (PRINCIPAL_INVESTIGATOR)
University of TexasHoustonTexas77030
Elena Moreno
[email protected]
713-500-5638
Alex Choi (PRINCIPAL_INVESTIGATOR)

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HMH Jersey Shore University Medical Center· Neptune City, NJUniversity of Texas· Houston, TX

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