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)

Phagenesis Limited (UK)0 sites255 target enrollmentOctober 28, 2014

Overview

Registry

who.int

Start Date

October 28, 2014

End Date

May 1, 2018

Last Updated

5 years ago

Study Type

Observational

Sex

All

Sponsor

Phagenesis Limited (UK)

•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

•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