A European registry to observe the use of the Phagenyx devices for the treatment of patients with swallowing difficulties.
| ISRCTN | ISRCTN87110165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87110165 |
| Protocol serial number | AHE02 |
| Sponsor | Phagenesis Limited (UK) |
| Funder | Phagenesis Limited (UK) |
- Submission date
- 16/10/2014
- Registration date
- 28/10/2014
- Last edited
- 09/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Patients suffering from a variety of conditions such as stroke and Parkinsons disease often experience difficulty with swallowing. This is known as neurogenic dysphagia. A common problem caused by neurogenic dysphagia is that food or drinks may go down the wrong way and end up in the lungs. This can result in serious chest infections. This can make recovery from neurogenic dysphagia more complicated and often, alternative feeding methods are proposed as a therapy. To treat the symptoms of neurogenic dysphagia, patients are often given special training on swallowing techniques. However, this doesnt always work and some patients end up needing long-term feeding through a tube surgically placed in their stomach. Alternative treatments are available. One of these is called Pharyngeal Electrical Stimulation (PES), which is a simple and harmless technique for treating neurogenic dysphagia. The Phagenyx treatment is given through a tube inserted into the throat and is very similar to the type of tube used to temporarily feed people with swallowing difficulties. It can also be used to provide medicine and liquids. The treatment involves stimulating the nerves in the throat (pharynx) for 10 minutes each day for 3 days in a row to improve swallowing function. The intensity or level of the stimulation is adjusted on each day so that it is at the right level for the patient. Scientific research on shows that Phagenyx treatment can help improve swallowing. This previous research has mainly been performed in stroke patients, but other patients suffering from neurogenic dysphagia can also be treated by the device and may benefit from the treatment. Here, we will document the regular use of the Phagenyx treatment device in a registry.
Who can participate?
Patients aged at least 18 and have been identified as having neurogenic dysphagia due to a stroke, Parkinsons disease, Multiple Sclerosis or have been involved in an accident affecting the brain or are receiving artificial ventilation to help with breathing.
What does the study involve?
This study is to documenting the regular use of the Phagenyx treatment devices in the real world. It observes how the devices work and documents the potential benefit (or lack of benefit) of the treatment in patients suffering from a variety of conditions that have caused difficulties in swallowing. It does not require any specific medical procedures to be done, other than those that are normally offered to patients with swallowing difficulties as standard treatment, which includes the Phagenyx treatment. As such, there are no experimental parts of this study. The intent is to only collect clinical data related to the Phagenyx treatment and its effects on neurogenic dysphagia.
What are the possible benefits and risks of participating?
In general, all procedures in this study are well tolerated by patients and are part of their routine care. Although the Phagenyx treatment is safe, it is not impossible that an unanticipated risk may occur during the study, but the chances of this happening are small and steps have been taken to make sure it is as safe as possible for patients to take part. All patients in the study will be carefully watched for any side effects. Specifically the risks and unwanted events that could occur can be listed as follows:
1. Insertion of tubes into the throat: The insertion of the treatment tubes through the nose can cause mild but temporary irritation of the nose or throat. Experienced staff will carry out this procedure to minimise the discomfort. There has been no cases of harmful complications caused by the insertion of such tubes in previous studies.
2. Electrical stimulation of the throat: The electrical stimulation can sometimes cause a moderate warm sensation at the back of the throat but this sensation is not painful.
Where is the study run from?
Participating hospitals across Europe, the Middle East, Africa and Canada.
When is the study starting and how long is it expected to run for?
January 2015 to January 2017
Who is funding the study?
Phagenesis Limited (UK)
Who is the main contact?
Dr Jaak Minten
Jaak.minten@fakkel-bvba.com
Contact information
Scientific
FAKKEL-BVBA
Pellenstraat 7
Landen
3400
Belgium
| Phone | +32 (0) 475923149 |
|---|---|
| Jaak.minten@fakkel-bvba.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective, single-arm, observational clinical follow-up study. |
| Secondary study design | Multi-centre |
| Study type | Participant information sheet |
| Scientific title | A prospective, single-arm, observational clinical follow-up study on the application of PHAryngeal electrical stimulation for treatment of neurogenic Dysphagia: a European Registry (PHADER) |
| Study acronym | PHADER |
| Study objectives | There is no specific hypothesis being tested in this registry-type of study: the purpose is to gather more evidence on the use and clinical outcomes of the Phagenyx products when used in daily practice (a real world environment) to treat swallowing difficulties caused by various conditions that affect the brain and its control of swallowing (known as 'neurogenic dysphagia'). |
| Ethics approval(s) | 1. All UK Sites: NRES Committee East of England - Cambridge Central, 22/04/2015, REC ref: 15/EE/0047 2. Austria: 2.1. Klagenfurt: Ethikkommision des Landes Kärten, 03/12/2015, Ref: A 16/14 2.2. Linz: Ethikkommision des Landes Oberösterreich, 27/08/2016, Ref: B-101-15 2.3. Innsbruck: Ethikkommision der Medizinischen Universtät Innsbruck, 30/11/2015, Ref: AN2014-0361 344/4.21 3508.8 3. Germany: 3.1. Munster (Lead ethics committee for Germany): Die Ethic-Kommission der Ärztekammer Westfalen-Lipp und der Westfälischen Wilhelms-Universität Münster, 14/07/2015, Ref: 2014-630-f-S 3.2. Hamburg (Local approval): Ethikkommision der Ärztekammer Hamburg, 11/12/2015, Ref: MC-367/15 Ethics submissions have also been made for two additional sites in Germany and Austria and are pending review. |
| Health condition(s) or problem(s) studied | Neurogenic dysphagia |
| Intervention | We are conducting a post-market-release observational study of our device. All treatments delivered in this study are considered standard practice. The Phagenyx treatment is given through a tube inserted into the throat and is very similar to the type of tube used to temporarily feed people with swallowing difficulty. It can also be used to provide medicine and liquids. The treatment involves stimulating the nerves in the throat (pharynx) for 10 minutes each day for 3 days in a row to improve swallowing function. The intensity or level of the stimulation is adjusted on each day so that it is at the right level for the patient. Observations will be made at: 1. Screening 2. Baseline (before to first treatment) 3. Last day of treatment (Day 0) 4. Follow-up assessment 1: 24-72hrs (after day 0) 5. Follow-up assessment 2: Day 7 to day of discharge (<21 days) (after day 0) 6. Follow-up assessment 3: Day 60-120 (after day 0) The total duration of follow-up will therefore be up to 120 days after the final day of treatment. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
The primary objective is assessed by means of two standard functional scoring systems and one instrumental scoring system: |
| Key secondary outcome measure(s) |
The secondary objectives are assessed by means of the following clinical data at one or more time points: baseline, at time intervals of 24-72 hrs, at pre-hospital discharge and at three months |
| Completion date | 01/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Total final enrolment | 255 |
| Key inclusion criteria | Patients are eligible for study participation if they: 1. Are suspected to have oropharyngeal dysphagia with a Dysphagia Severity Ratings Scale (DSRS) score of 6 or higher 2. When eating independency would be jeopardised by partial or total paralysation of upper extremities and have a Functional Oral Intake Scale (FOIS) score equal to or lower than 5 3. When no oral food intake is possible and DSRS score is 12 and FOIS-score is 1 and have a Penetration-Aspiration Score (PAS) of 4 or higher 4. Have a well identified dysphagia causing neurological event such as, but not limited to, stroke or brain injury, potentially but not necessarily leading to the need of long-term mechanical ventilation or a tracheostomy 5. Are over 18 years old 6. Give themselves or have legal relatives/authorities representing themselves to give voluntary written informed consent |
| Key exclusion criteria | 1. Have an undefined date of medical event causing the dysphagia 2. Suffer from non-neurogenic dysphagia (e.g. cancer) 3. Participate in any other study potentially influencing the outcome of the Phagenyx treatment, both medicinal or medical device product related 4. Receive or have received within one month prior to the intended Phagenyx treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia 5. Have a cardiac pacemaker or a cardioverter defibrillator implanted unless the device can be switched off completely at the time of treatment delivery 6. Have experienced an oesophageal perforation, or have an oesophageal stricture or pouch; 7. Have an unstable cardiopulmonary status 8. Receive continuous oxygen treatment or have the equipment for such treatment permanently in place preventing the positioning of the Phagenyx Catheter (this does not exclude patients who are intubated or have a tracheostomy where an inflated balloon creates a firm barrier between the space where oxygen might be present (trachea/lungs) and the space where the electrical stimuli are delivered (oropharynx), or patients that can have the oxygen treatment temporarily stopped and equipment removed during Phagenyx treatment) 9. Are pregnant or nursing women 10. Require emergency treatment, preventing appropriate conduct of the subject informed consent process 11. Have a life expectancy less than the duration of the patients follow up period, i.e. less than three months |
| Date of first enrolment | 01/03/2015 |
| Date of final enrolment | 01/12/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
- Austria
- Germany
Study participating centres
City Hospital Campus
Hucknall Road
Nottingham
NG3 5LX
United Kingdom
Münster
48129
Germany
Dehnhaide 120
Hamburg
22081
Germany
Parzivalplatz 4
München
80804
Germany
Kolbermoorer Str. 72
Bad Aibling
83043
Germany
Feschingstr. 11
Klagenfurt am Wörthersee
Klagenfurt
9020
Austria
Zirl
6170
Austria
Linz
4020
Austria
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom
Poole
BH15 2JB
United Kingdom
Linz
4021
Austria
Bad Staffelstein
96231
Germany
Diessemer Bruch 81
Krefeld
47805
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2020 | 09/12/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
24/03/2016: Ethics approval information added.
