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Phagenyx® Registry Study

NCT ID: NCT06866418

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-15

Study Completion Date

2036-09-30

Brief Summary

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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).

Detailed Description

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The study will consist of a Treatment Group and a Control Group. The Treatment Group will include patients who have undergone PES treatment for severe dysphagia. The Control Group will consist of patients that qualify for PES treatment but are not treated with PES in the time period prior to implementing PES. Patients will be treated per standard of care at each institution. Each Treatment patient will receive treatment with PES in addition to other standard of care dysphagia therapies. Control subjects will receive standard of care dysphagia therapies only (no PES or other electrical stimulation therapies for dysphagia are permitted). Performance of the Phagenyx® System will be analyzed by comparing treatment outcomes for patients in the PES Group compared to patients in the Control Group.

The study will include patients with severe dysphagia post stroke. The main clinical outcomes will be assessed using the participating sites' standard of care methodology and will evaluate improvements in swallowing and reduction in associated treatments and complications.

Conditions

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Dysphagia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control Group

Patient requires a nasogastric feeding tube for severe dysphagia and required dysphagia treatment

No interventions assigned to this group

Treatment Group

Patients who have undergone PES treatment for severe dysphagia.

1. Phagenyx® System Group Patients

Intervention Type DEVICE

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

Interventions

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1. Phagenyx® System Group Patients

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phagenesis Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HMH Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Site Status RECRUITING

University of Texas

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Miller

Role: CONTACT

Phone: 248-420-3292

Email: [email protected]

Facility Contacts

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Alexandria Nwar

Role: primary

Elena Moreno

Role: primary

Other Identifiers

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AHE-07

Identifier Type: -

Identifier Source: org_study_id