Recruiting

Pharyngeal Electrical Stimulation

Sponsor:

Phagenesis Ltd.

Code:

NCT06866418

Conditions

Dysphagia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

1. Phagenyx® System Group Patients

Study Details

Brief 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).

Conditions

Dysphagia

Study ID

NCT06866418

Start date

Sep 15, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2036

Anticipated

Primary completion date

Sep, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Control Group

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

Treatment Group

Patients who have undergone PES treatment for severe dysphagia.

Interventions

1. Phagenyx® System Group Patients

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

Primary outcome measure

  • Swallowing safety [ Time Frame: Baseline to 2 (+1 days) post final PES treatment (Approximately 6 days). ]
  • Nutritional Management [ Time Frame: Baseline to Hospital Discharge (up to approximately 30 days) ]

Central Contacts and Locations

Central contacts

Jennifer Miller

248-420-3292jennifer.miller@phagenesis.com

Locations

Banner University Medical Center

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Karla Granados

480-412-6859granados13@arizona.edu

Principal Investigator:

Andrei Alexandrov, MD

HMH Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Contacts

Alexandria Nwar

732-776-3681alexandria.nuwar@hmhn.org

Principal Investigator:

Sanskriti Mishra, MD

University of Texas

Recruiting

Houston, Texas, United States, 77030

Contacts

Elena Moreno

713-500-5638Elena.Espino@uth.tmc.edu

Principal Investigator:

Alex Choi, MD

More Information

Sponsor

Phagenesis Ltd.

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Phagenesis Ltd. on 2026-07-09.