A European registry to observe the use of the Phagenyx devices for the treatment of patients with swallowing difficulties.

Not Applicable

Completed

• Conditions: eurogenic dysphagia; Signs and Symptoms

• Registration Number: ISRCTN87110165
• Lead Sponsor: Phagenesis Limited (UK)

Brief Summary

2020 results in https://doi.org/10.1016/j.eclinm.2020.100608 (added 09/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-28
• Study Completion: 2018-05-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 255

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

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 patient?s follow up period, i.e. less than three months

Study & Design

• Study Type: Observational
• Study Design: Not specified