DysphagiaRESTORE-USNCT06866418
Phagenyx® Registry Study
An observational study of Dysphagia, run by Phagenesis Ltd. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dysphagia
- What is being tested?
- 1. Phagenyx® System Group Patients
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2025to Sep 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Texas
Houston, Texas, 77030
Elena Moreno, 713-500-5638, Elena.Espino@uth.tmc.edu
Alex Choi, MD
- Recruiting
HMH Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Alexandria Nwar, 732-776-3681, alexandria.nuwar@hmhn.org
Sanskriti Mishra, MD
- Recruiting
Banner University Medical Center
Phoenix, Arizona, 85006
Karla Granados, 480-412-6859, granados13@arizona.edu
Andrei Alexandrov, MD
About this study
Official title: Phagenyx® Registry Study: Evaluating Swallowing Therapy Outcomes and Recovery in the U.S.
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).
Read the detailed description
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
- Dysphagia
- Being tested
- 1. Phagenyx® System Group Patients
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Phagenyx® System Group PatientsDevice
Patients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 1. Phagenyx® System Group Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing safety
Swallowing safety based on the change in Penetration Aspiration Scale (PAS) score from baseline (pre-PES treatment) to 2 (+1 days) post PES treatment.
Measured: Baseline to 2 (+1 days) post final PES treatment (Approximately 6 days).
Nutritional Management
Nutritional management improvement based on the change in Functional Oral Intake Score (FOIS) from baseline (pre-PES treatment) to hospital discharge
Measured: Baseline to Hospital Discharge (up to approximately 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start15 Sep 2025
- Primary completionSep 2035 (estimated)
- Study completionSep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phagenesis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866418
- Sponsor's protocol ID
- AHE-07
- Acronym
- RESTORE-US
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phagenyx® Registry Study: Evaluating Swallowing Therapy Outcomes and Recovery in the U.S.
- ClinicalTrials.gov ID
- NCT06866418
- Acronym / sponsor ID
- RESTORE-US / AHE-07
- Conditions
- Dysphagia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Phagenesis Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Sep 2035 (estimated)
- Study completion
- Sep 2036 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Patient requires a nasogastric feeding tube for severe dysphagia and required dysphagia treatment |
| Treatment Group | – | Device: 1. Phagenyx® System Group PatientsPatients who have undergone PES treatment for severe dysphagia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. Phagenyx® System Group PatientsPatients who have undergone Pharyngeal Electrical Stimulation (PES) treatment for severe dysphagia using the Phagenyx® System | Device | Treatment Group |
Primary outcome
Swallowing safety
Time frame: Baseline to 2 (+1 days) post final PES treatment (Approximately 6 days).
Swallowing safety based on the change in Penetration Aspiration Scale (PAS) score from baseline (pre-PES treatment) to 2 (+1 days) post PES treatment.
Nutritional Management
Time frame: Baseline to Hospital Discharge (up to approximately 30 days)
Nutritional management improvement based on the change in Functional Oral Intake Score (FOIS) from baseline (pre-PES treatment) to hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Dysphagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by Phagenesis Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Miller (248-420-3292, jennifer.miller@phagenesis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing safety (time frame: Baseline to 2 (+1 days) post final PES treatment (Approximately 6 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.