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Shock to the throat: new device helps stroke patients swallow

NCT ID NCT06866418

Symptom relief Sponsor: Phagenesis Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This study looks at a device called Phagenyx that uses mild electrical pulses to stimulate the throat muscles in stroke survivors who have severe trouble swallowing. Researchers will compare patients who received this treatment with those who did not, to see if it helps them eat and drink more safely. The goal is to improve recovery and reduce the need for feeding tubes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dysphagia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Banner University Medical Center

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • HMH Jersey Shore University Medical Center

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • University of Texas

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

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