None listed
Conditions
Brief summary
Biomedical devices, such as artificial joints and pacemakers, are accepted and commonly used in medicine. While great progress in biomedical devices has been made for many other disorders, there is currently no device available to help with swallowing.. We have developed an implantable biomedical device (Swallow Expansion Device, SED) that assists with swallowing by allowing the individual to mechanically pull open the valve (upper esophageal sphincter, UES) at the top of the oesophagus, which will allow food and liquid to safely enter the oesophagus. This device is intended for use in people with severe swallow impairments who still wish to be able to eat something by mouth. Our hypothesis is that the SED can be safely implanted and integrated into the neck of a subject under local anaesthetic, and allow mechanical distraction of the UES to assist in swallow functions.
Interventions
Pilot study in which 5 subjects with severe swallow difficulty and aspiration that has failed all available treatment options will be implanted with a small plate-and-pin device (the Swallow Expansion Device, SED). This will be attached to the cricoid cartilage to allow for manual distraction of the upper oesophageal sphincter. Implantation will be performed under local anaesthetic. Eight weeks healing will be allowed before distraction begins. The SED may remain in place or be removed under
Pilot study in which 5 subjects with severe swallow difficulty and aspiration that has failed all available treatment options will be implanted with a small plate-and-pin device (the Swallow Expansion Device, SED). This will be attached to the cricoid cartilage to allow for manual distraction of the upper oesophageal sphincter. Implantation will be performed under local anaesthetic. Eight weeks healing will be allowed before distraction begins. The SED may remain in place or be removed under local anaesthetic at any time. Implantation will be performed only by the Principle Investigator, a Fellowship trained Laryngologist. Local anaesthetic used will be 0.5% bupivacaine with adrenaline (max volume 20ml) injected via 25G needle. Use of the device (after the specified bedding in time) will involve manual traction on the stem which will then pull the upper oesophageal sphincter open to allow for food passage. This requires some manual dexterity and ability to lift a 2kg weight (this is in the inclusion criteria).
Sponsors
Waitemata District Health Board
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Profound oropharyngeal dysphagia (with or without feeding tube) of greater than 12 months duration, as documented by the prevalence of aspiration on fluoroscopic swallow study. 2) Age > 18 years, acceptable forms of documentation for verification of age include birth certificate, passport, and/or driver’s license. 3) Diminished UES opening defined as less than .55 cm for individuals less than 65 years of age and less than .40 cm for individuals over 65 years of age on fluoroscopic swallow study. 4) Failure of > 3 months of dysphagia therapy within 3 months of study enrollment. 5) No documented history of noncompliance with feeding recommendations. 6) Cognition that is within normal limits, as evidenced by a Mini Mental State Exam score greater than 25. 7) Manual dexterity that allows manipulation of the device. 8) Physical strength to pull the SED forward, as evidenced by the ability to lift a 2kg weight off of a table and keep it elevated for 10 seconds. 9) Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations. 10) Bilateral vocal fold mobility or unilateral vocal fold immobility in which the individual is able to attain complete glottic closure as evidenced on endoscopy.
Exclusion criteria
1) Profound oropharyngeal dysphagia < 12 months duration. 2) Esophageal phase dysphagia as defined as personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, stricture, eosinophilic esophagitis, erosive peptic esophagitis, and/or systemic disease affecting the esophagus. 3) Normal UES opening, as evidenced by UES opening greater than .55 cm for individuals under 65 years of age and greater than .40 cm for individuals over 65 years of age on fluoroscopic swallow study. 4) Currently pregnant, as evidenced by a positive result on a pregnancy test if the patient is within child bearing age (younger than 45 years of age). 5) Age < 18 years 6) Not having received dysphagia therapy 7) Lack of manual dexterity to operate swallowing expansion device. 8) Inability to lift a 2kg weight off of a table and keep it elevated for 10 seconds. 9) Lack of cognitive ability to operate swallowing expansion device or provide informed consent. 10) Active tumor involving the cricoid or laryngeal cartilage. 11) Known allergic reaction to titanium as evidenced by personal history of allergic or adverse reaction to titanium. 12) Infection of cartilage, head, and/or neck at time of evaluation and/or implantation as documented by recent imaging study or abnormal physical examination. 13) Presence of a tracheotomy tube or airway obstruction necessitating a tracheotomy tube. 14) A documented history of noncompliance with recommendations or inability to attend follow up reviews. 15) Patients with an insensate larynx. Laryngeal sensation will be assessed with laryngopharyngeal sensory testing by laryngeal adductor reflex response on endoscopy. 16) Patients with a current, at the time of evaluation, and/or history of Zenker’s diverticulum. 17) Patients with sialorrhea at the time of evaluation with or without oral commissure incompetence. 18) Patients with profound xerostomia at the time of evaluation. 19) Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation. 20) Patients with a current, at the time of evaluation, and/or history of immunosuppression, as defined by the patient having a diagnosed immunodeficiency disorder or on immunosuppressive medication. 21) Patients with a current, at the time of evaluation, and/or history of coagulopathy, as defined by the patient having a diagnosed coagulation disorder or on anticoagulation medication (e.g. baby aspirin, OTC non steroidal antinflammatories, herbal agents, Warfarin, clopidogrel) that cannot be temporarily stopped for the procedure. 22) Patients taking sedatives, narcotics, muscle-relaxants, anxiolytics, medical marijuana, alcohol, nicotine, medicinal nicotine, or other mind-altering medications that may affect safe patient use of the swallowing device. 23) Patients with bilateral vocal fold immobility in any position, as evidenced on endoscopy. 24) Patients with unilateral vocal fold immobility and unable to attain complete glottic closure, as evidenced on endoscopy. 25) Patients with current, at the time of evaluation, and/or documented history of subglottic stenosis, as evidenced on endoscopy. 26) Patients with current, at the time of evaluation, and/or documented history of airway obstruction, as evidenced on endoscopy. 27) Patients with a life expectancy < 2 years.
Outcome results
None listed