DysphagiaPhINESTNCT03840395
The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy
A study testing Pharyngeal Electrical Stimulation (PES) in people with Dysphagia, run by Phagenesis Ltd. at 5 sites in 3 countries.
Trial summary
This is a prospective, multi-site, randomised, sham-controlled, single-blind (outcome assessor-blinded) study designed to assess the effects of Pharyngeal Electrical Stimulation (PES) (using Phagenyx®) for the treatment of oropharyngeal dysphagia after invasive mechanical ventilation (of any duration) by means of naso… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Pharyngeal Electrical Stimulation (PES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 17 Jun 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- An individual who meets any of the following criteria will be excluded from enrolment in this study:
- Nasal anatomical deformity, nasal airway obstruction; patient who have had recent oral, nasal or oesophageal surgery or patient presenting with facial and/or cranial fractures or any other circumstance (e.g. history of oesophageal perforation, stricture, pouch, resection or rupture) where the placement of a standard nasogastric feeding tube (NGT) would be deemed unsafe,
- Cardiac or respiratory condition that might render the insertion (placement) of a catheter into the throat unsafe,
- Permanently implanted electrical devices,
- Are pregnant (pregnancy test) or known lactating women,
- Have non-neurogenic dysphagia (e.g. Cancer-related),
Show all 13Show fewer
- Any prior tracheostomy,
- Patients who at the time of extubation have any treatment limitation (i.e., palliative care, life expectancy less than 48 hours, or are moribund), that prevents or would prevent compliance with study-specific instructions or procedures (as judged by the investigator),
- Severe cognitive impairment or other reasons that prevents compliance with study-specific instructions or procedures (as judged by the investigator),
- Previous history of dysphagia of any origin,
- Pre-existing tube feeding of any form (e.g. percutaneous gastric/enteral feeding tube related to previous injuries indicating previous dysphagia. NGTs are not an exclusion criterion),
- 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
5 sites in 3 countries.
5 sites in 3 countries
Austria3 sites
Medizinische Universität Innsbruck - Medizinische Universität Innsbruck
Innsbruck, 6020 INNSBRUCK
Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin
Innsbruck, 6020 INNSBRUCK
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I
Innsbruck, 6020 INNSBRUCK
Germany1 site
Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin
Hamburg, 20246 HAMBURG
Switzerland1 site
University Clinic for Intensive Medicine, Inselspital
Bern, CH-3010
About this study
Official title: The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy: a Prospective, Multi-site, Randomised, Sham-controlled, Single-blind (Outcome Assessor-blinded) Study.
This is a prospective, multi-site, randomised, sham-controlled, single-blind (outcome assessor-blinded) study designed to assess the effects of Pharyngeal Electrical Stimulation (PES) (using Phagenyx®) for the treatment of oropharyngeal dysphagia after invasive mechanical ventilation (of any duration) by means of naso or oro-tracheal tube in critically ill intensive care unit (ICU) patients.
Read the detailed description
The PhINEST study is designed to assess the effects of Pharyngeal Electrical Stimulation (PES) (using Phagenyx®) for treatment of oropharyngeal dysphagia after invasive mechanical ventilation (of any duration) by means of naso or oro-tracheal tube in critically ill intensive care unit (ICU) patients.
The main clinical outcomes assessing unsafe swallows and dysphagia severity will be measured using the gold standard, i.e. Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and bedside swallowing assessments on day 2* after completion of final PES treatment.
Randomisation will be on a 1:1 basis at each site stratified for neurological vs. non-neurological reason for admission (Acute Physiology and Chronic Health Evaluation (APACHE) IV diagnostic group). Patients will receive either PES/sham treatment in addition to standard supportive ICU care and standard of care treatments for dysphagia. Administration of all protocol-specific assessments will be conducted by personnel blinded to treatment assignment.
The study will follow an adaptive population enrichment and sample size re-estimation (SSR) design with one interim look. The study will start with a planned sample size of 200 patients and a maximum (evaluable) sample size of 360. Interim analysis after completion of approximately 140 (evaluable) patients will determine:
- futility stopping; OR II. sample size increase for the overall sampled population; OR III. Enrichment based on the composite primary endpoint by pre-defined subgroups (neurological vs. non-neurological reason for admission according to APACHE IV diagnostic groups). Thus enrollment of patients in the non-performing sub-group will be stopped at the interim while a sample-size re-estimation based on conditional power will be carried out for the other sub-group.
All interim decisions will be based on conditional power which for the Finkelstein-Schoenfeld (FS)-statistic will need to be computed via Monte-Carlo simulations.
Up to thirty (30) investigational sites across Europe are planned to participate in this study which is expected to last 48 months from first patient first visit to last patient last visit. Patients will be assessed at the following intervals: screening, baseline, on day 2* after completion of final study treatment, 7 ± 1 days after final study treatment and 14 ± 1 days after final study treatment (or hospital discharge if earlier). 30-day and 90-day mortality data will also be collected from the patients medical notes/electronic heath records/telephone call (no additional visit required).
*The day two (FU1) visit is to be conducted on the second day (~24hrs) following final PES treatment but may, under certain circumstances, be conducted upon/by the fourth day (~60 hrs) following final study treatment in instances where the final study treatment is delivered on late Friday and where FEES assessment is only possible early on Monday as no weekend FEES service is available at the investigation site.
- Conditions
- Dysphagia
- Being tested
- Pharyngeal Electrical Stimulation (PES)
- Keywords
- Dysphagia, Extubation, Intensive Care Unit, Pharyngeal Electrical Stimulation, Oropharyngeal Dysphagia, Mechanical Ventilation, Critically ill patients, Post-Extubation Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal Electrical Stimulation (PES)Device
Also called Phagenyx
The Phagenyx® system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation to the oropharynx. The Phagenyx® devices are CE labelled (2012) and will be used in accordance with their intended use label.
| Study group | Role | What they receive |
|---|---|---|
| Active PES | Active comparator | Patients randomized to receive active Pharyngeal Electrical Stimulation (PES) via a Phagenyx Catheter. Receives: Device: Pharyngeal Electrical Stimulation (PES) |
| Sham PES | Sham comparator | Patients randomized to sham will not receive any Pharyngeal Electrical Stimulation (PES) but will still have the Phagenyx Catheter inserted. Receives: Device: Pharyngeal Electrical Stimulation (PES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Phagenyx® treatment in reducing severity of unsafe swallows - Penetration-Aspiration Scale (PAS) Scores
Analysis of a two endpoints composite (FS-statistic) on a hierarchy of clinical priorities:
Endpoint 1 - Swallowing safety based on worst PAS score in up to 4 thin (water) boli for each patient during FEES assessment converted to a trichotomised ordinal response of safe (PAS 1-3), penetration (PAS 4-5), or aspiration (PAS 6-8).
The PAS provides a scoring system for airway closure and clearance during FEES. The PAS is a validated 8-point scale quantifying penetration and aspiration events primarily by the depth to which material passes into the airway and whether or not it is ejected.
Measured: Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment
Effectiveness of Phagenyx® treatment in reducing the severity of unsafe swallows - Dysphagia Outcome and Severity Score (DOSS) score
Analysis of a two endpoints composite (FS-statistic) on a hierarchy of clinical priorities:
Endpoint 2 - DOSS scale score determined by bedside assessment.
The DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment and make recommendations for diet level, independence level, and type of nutrition.
- Severe dysphagia
- Moderately severe dysphagia
- Moderate dysphagia
- Mild-moderate dysphagia
- Mild dysphagia
- Functional limitation and modified independence
- Normal in all situations
Measured: 7±1 days after the final Phagenyx® treatment
Secondary outcomes (11)
Effectiveness of Phagenyx® treatment in improving DOSS score.
Changes in nutritional management and severity of dysphagia as measured by the DOSS score.
Measured: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on time from to feeding tube removal.
Changes in nutritional management and severity of dysphagia as measured by time from randomisation to removal of feeding tube.
Measured: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on time to oral intake.
Changes in nutritional management and severity of dysphagia as measured by time to oral intake (if applicable).
Measured: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on total days of enteral feeding.
Changes in nutritional management and severity of dysphagia as measured by total days of enteral feeding.
Measured: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment in improving Functional Oral Intake Scale (FOIS) score.
Changes in nutritional management and severity of dysphagia as measured by the FOIS score.
The FOIS provides a scoring system to document the functional level of oral intake of food and liquid in patients with dysphagia. It is a validated 7-point ordinal scale easily completed from information contained in medical charts, dietary journals, and/or patient reports.
- Nothing by mouth
- Tube dependent with minimal attempts of food or liquid
- Tube dependent with consistent intake of liquid or food
- Total oral diet of a single consistency
- Total oral diet with multiple consistencies but requiring special preparation or compensations
- Total oral diet with multiple consistencies without special preparation, but with specific food limitations
- Total oral diet with no restriction
Measured: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment in improving Dysphagia Severity Rating Scale (DSRS) score.
Changes in nutritional management and severity of dysphagia as measured by the DSRS score.
The DSRS is a simple to use, validated 13-point scale composed of a 3-component score that includes feeding independence, but nutrition level and diet modification is split into the components of liquid feeding and overall diet consistency. The DSRS is the sum of the scores of each of the 3 individual components (range 0-4 for each component) rather than a combination of the three components into an ordinal scale.
Best score = 0 (no dysphagia) Worst score = 12 (NPO)
Measured: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on time from extubation to ICU discharge
General health outcome measured by time from extubation to ICU discharge (days).
Measured: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on length of stay in ICU
General health outcome measured by length of stay in ICU (days).
Measured: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on length of stay in hospital.
General health outcome measured by length of stay in hospital (days).
Measured: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on number of patients with re-intubation during hospital stay
General health outcome measured by number of patients with re-intubation during hospital stay.
Measured: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on mortality
General health outcome measured by 30-day and 90-day mortality.
Measured: Up to 90 days after completion of the final Phagenyx® treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start17 Jun 2019
- Primary completion1 Aug 2025
- Study completion31 Dec 2025
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phagenesis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, Cytel Inc.
- Responsible party
- Sponsor
- Investigators
- Joerg Schefold, MD, Principal investigator, University Clinic for Intensive Medicine, Inselspital, University of BernMicheal Joannidis, MD, Principal investigator, Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin IChristopher Rugg, MD, Principal investigator, Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und IntensivmedizinAlois Schiefecker, MD, Principal investigator, Medizinische Universität Innsbruck - Universitätsklinik für NeurologieStefan Kluge, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf - Klinik für Intensivmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840395
- Sponsor's protocol ID
- AHE-06
- Acronym
- PhINEST
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2019
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schefold JC, Backlund M, Ala-Kokko T, Zuercher P, Mukherjee R, Mistry S, Mayer SA, Dziewas R, Bakker J, Jakob SM. The PhINEST study - Pharyngeal ICU Novel Electrical Stimulation Therapy: Study protocol of a prospective, multi-site, randomized, sham-controlled, single-blind (outcome assessor-blinded) study. Medicine (Baltimore). 2020 Mar;99(11):e19503. doi: 10.1097/MD.0000000000019503.
PubMed 32176093Likar R, Aroyo I, Bangert K, Degen B, Dziewas R, Galvan O, Grundschober MT, Kostenberger M, Muhle P, Schefold JC, Zuercher P. Management of swallowing disorders in ICU patients - A multinational expert opinion. J Crit Care. 2024 Feb;79:154447. doi: 10.1016/j.jcrc.2023.154447. Epub 2023 Nov 2.
PubMed 37924574
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PhINEST Study - Pharyngeal ICU Novel Electrical Stimulation Therapy: a Prospective, Multi-site, Randomised, Sham-controlled, Single-blind (Outcome Assessor-blinded) Study.
- ClinicalTrials.gov ID
- NCT03840395
- Acronym / sponsor ID
- PhINEST / AHE-06
- Conditions
- Dysphagia
- Keywords
- Dysphagia, Extubation, Intensive Care Unit, Pharyngeal Electrical Stimulation, Oropharyngeal Dysphagia, Mechanical Ventilation, Critically ill patients, Post-Extubation Dysphagia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Phagenesis Ltd.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA, Cytel Inc.
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 Feb 2019 (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.
This is a prospective, multi-site, randomised, sham-controlled, single-blind (outcome assessor-blinded) study designed to assess the effects of Pharyngeal Electrical Stimulation (PES) (using Phagenyx®) for the treatment of oropharyngeal dysphagia after invasive mechanical ventilation (of any duration) by means of naso or oro-tracheal tube in critically ill intensive care unit (ICU) patients.
Detailed description
The PhINEST study is designed to assess the effects of Pharyngeal Electrical Stimulation (PES) (using Phagenyx®) for treatment of oropharyngeal dysphagia after invasive mechanical ventilation (of any duration) by means of naso or oro-tracheal tube in critically ill intensive care unit (ICU) patients.
The main clinical outcomes assessing unsafe swallows and dysphagia severity will be measured using the gold standard, i.e. Fiberoptic Endoscopic Evaluation of Swallowing (FEES) and bedside swallowing assessments on day 2* after completion of final PES treatment.
Randomisation will be on a 1:1 basis at each site stratified for neurological vs. non-neurological reason for admission (Acute Physiology and Chronic Health Evaluation (APACHE) IV diagnostic group). Patients will receive either PES/sham treatment in addition to standard supportive ICU care and standard of care treatments for dysphagia. Administration of all protocol-specific assessments will be conducted by personnel blinded to treatment assignment.
The study will follow an adaptive population enrichment and sample size re-estimation (SSR) design with one interim look. The study will start with a planned sample size of 200 patients and a maximum (evaluable) sample size of 360. Interim analysis after completion of approximately 140 (evaluable) patients will determine:
- futility stopping; OR II. sample size increase for the overall sampled population; OR III. Enrichment based on the composite primary endpoint by pre-defined subgroups (neurological vs. non-neurological reason for admission according to APACHE IV diagnostic groups). Thus enrollment of patients in the non-performing sub-group will be stopped at the interim while a sample-size re-estimation based on conditional power will be carried out for the other sub-group.
All interim decisions will be based on conditional power which for the Finkelstein-Schoenfeld (FS)-statistic will need to be computed via Monte-Carlo simulations.
Up to thirty (30) investigational sites across Europe are planned to participate in this study which is expected to last 48 months from first patient first visit to last patient last visit. Patients will be assessed at the following intervals: screening, baseline, on day 2* after completion of final study treatment, 7 ± 1 days after final study treatment and 14 ± 1 days after final study treatment (or hospital discharge if earlier). 30-day and 90-day mortality data will also be collected from the patients medical notes/electronic heath records/telephone call (no additional visit required).
*The day two (FU1) visit is to be conducted on the second day (~24hrs) following final PES treatment but may, under certain circumstances, be conducted upon/by the fourth day (~60 hrs) following final study treatment in instances where the final study treatment is delivered on late Friday and where FEES assessment is only possible early on Monday as no weekend FEES service is available at the investigation site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active PES | Active comparator | Device: Pharyngeal Electrical Stimulation (PES)Patients randomized to receive active Pharyngeal Electrical Stimulation (PES) via a Phagenyx Catheter. |
| Sham PES | Sham comparator | Device: Pharyngeal Electrical Stimulation (PES)Patients randomized to sham will not receive any Pharyngeal Electrical Stimulation (PES) but will still have the Phagenyx Catheter inserted. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- An individual who meets any of the following criteria will be excluded from enrolment in this study:
- Nasal anatomical deformity, nasal airway obstruction; patient who have had recent oral, nasal or oesophageal surgery or patient presenting with facial and/or cranial fractures or any other circumstance (e.g. history of oesophageal perforation, stricture, pouch, resection or rupture) where the placement of a standard nasogastric feeding tube (NGT) would be deemed unsafe,
- Cardiac or respiratory condition that might render the insertion (placement) of a catheter into the throat unsafe,
- Permanently implanted electrical devices,
- Are pregnant (pregnancy test) or known lactating women,
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 |
|---|---|---|
| Pharyngeal Electrical Stimulation (PES)Also: PhagenyxThe Phagenyx® system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation to the oropharynx. The Phagenyx® devices are CE labelled (2012) and will be used in accordance with their intended use label. | Device | Active PES, Sham PES |
Primary outcome
Effectiveness of Phagenyx® treatment in reducing severity of unsafe swallows - Penetration-Aspiration Scale (PAS) Scores
Time frame: Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment
Analysis of a two endpoints composite (FS-statistic) on a hierarchy of clinical priorities: Endpoint 1 - Swallowing safety based on worst PAS score in up to 4 thin (water) boli for each patient during FEES assessment converted to a trichotomised ordinal response of safe (PAS 1-3), penetration (PAS 4-5), or aspiration (PAS 6-8). The PAS provides a scoring system for airway closure and clearance during FEES. The PAS is a validated 8-point scale quantifying penetration and aspiration events primarily by the depth to which material passes into the airway and whether or not it is ejected.
Effectiveness of Phagenyx® treatment in reducing the severity of unsafe swallows - Dysphagia Outcome and Severity Score (DOSS) score
Time frame: 7±1 days after the final Phagenyx® treatment
Analysis of a two endpoints composite (FS-statistic) on a hierarchy of clinical priorities: Endpoint 2 - DOSS scale score determined by bedside assessment. The DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment and make recommendations for diet level, independence level, and type of nutrition. 1. Severe dysphagia 2. Moderately severe dysphagia 3. Moderate dysphagia 4. Mild-moderate dysphagia 5. Mild dysphagia 6. Functional limitation and modified independence 7. Normal in all situations
11 secondary outcomes
Effectiveness of Phagenyx® treatment in improving DOSS score.
Time frame: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on time from to feeding tube removal.
Time frame: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on time to oral intake.
Time frame: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on total days of enteral feeding.
Time frame: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment in improving Functional Oral Intake Scale (FOIS) score.
Time frame: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment in improving Dysphagia Severity Rating Scale (DSRS) score.
Time frame: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on time from extubation to ICU discharge
Time frame: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on length of stay in ICU
Time frame: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on length of stay in hospital.
Time frame: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on number of patients with re-intubation during hospital stay
Time frame: Up to 14 ± 1 days after the final Phagenyx® treatment (or hospital discharge if earlier).
Effectiveness of Phagenyx® treatment on mortality
Time frame: Up to 90 days after completion of the final Phagenyx® treatment.
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 32176093Schefold JC, Backlund M, Ala-Kokko T, Zuercher P, Mukherjee R, Mistry S, Mayer SA, Dziewas R, Bakker J, Jakob SM. The PhINEST study - Pharyngeal ICU Novel Electrical Stimulation Therapy: Study protocol of a prospective, multi-site, randomized, sham-controlled, single-blind (outcome assessor-blinded) study. Medicine (Baltimore). 2020 Mar;99(11):e19503. doi: 10.1097/MD.0000000000019503.
- Derived from this study: PubMed 37924574Likar R, Aroyo I, Bangert K, Degen B, Dziewas R, Galvan O, Grundschober MT, Kostenberger M, Muhle P, Schefold JC, Zuercher P. Management of swallowing disorders in ICU patients - A multinational expert opinion. J Crit Care. 2024 Feb;79:154447. doi: 10.1016/j.jcrc.2023.154447. Epub 2023 Nov 2.
- PhINEST Study - Protocol ManuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Joerg Schefold, MD principal investigator
University Clinic for Intensive Medicine, Inselspital, University of Bern
Micheal Joannidis, MD principal investigator
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin I
Christopher Rugg, MD principal investigator
Medizinische Universität Innsbruck - Universitätsklinik für Anästhesie und Intensivmedizin
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal Electrical Stimulation (PES) in people with Dysphagia, run by Phagenesis Ltd. at 5 sites in 3 countries.
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 0 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria, Germany, Switzerland. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Phagenyx® treatment in reducing severity of unsafe swallows - Penetration-Aspiration Scale (PAS) Scores (time frame: Day 2 (~24 to ~60 hours) after the final Phagenyx® treatment). 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?
On the ClinicalTrials.gov record for NCT03840395, which also lists 2 linked publications.
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 14 May 2026.