Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients

This is an interventional treatment trial for Oropharyngeal Dysphagia (OPD) focused on measuring Feeding Tube Dependent Read More

Inclusion Criteria:

• Profound oropharyngeal feeding tube dependent dysphagia of greater than 12 months duration, as documented by the prevalence of aspiration on fluoroscopic swallow study.
• Must be receiving 100% of nutritional requirements by enterogastric tube.
• 18 years of age and older, acceptable forms of documentation for verification of age include birth certificate, passport, and/or driver's license.
• Diminished upper esophageal sphincter opening defined as less than .55 cm for individuals under 65 years of age and less than .40 cm for individuals over 65 years of age on fluoroscopic swallow study.
• Failure of > 3 months of dysphagia therapy within 3 months of study enrollment.
• No documented history of noncompliance with feeding recommendations.
• Cognition that is within normal limits, as evidenced by an Abbreviated Mental Test Score (AMTS) score greater than 6.
• Manual dexterity that is within normal limits for age, sex, and hand, as evaluated by a Block and Box Test (BBT).
• Physical strength to pull the SED forward, as evidenced by the ability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds.
• Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations and a normal Abbreviated Mental Test Score.
• 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:

• Profound oropharyngeal feeding tube dependent dysphagia < 12 months duration.
• 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.
• Able to safely consume any food or liquid by mouth, as documented by fluoroscopic swallow study.
• 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.
• Currently pregnant, as evidenced by a positive result on a pregnancy test if the patient is within child bearing age (younger than 60 years of age).
• 17 years of age and younger, acceptable forms of documentation for verification of age include birth certificate, passport, and/or license.
• Success full receipt of dysphagia therapy or < 3 months of dysphagia therapy within 3 months of study enrollment.
• Lack of manual dexterity to operate swallowing expansion device as determined by a Block and Box Test (BBT) score below the normal limits per age, sex, and hand.
• Inability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds.
• Lack of cognitive ability to operate swallowing expansion device or provide informed consent as evidenced by an Abbreviated Mental Test Score (AMTS) score less than 6.
• Active tumor involving the cricoid or laryngeal cartilage.
• Known allergic reaction to titanium as evidenced by personal history of allergic or adverse reaction to titanium.
• Infection of cartilage, head, and/or neck at time of evaluation and/or implantation as documented by recent imaging study or abnormal physical examination.
• Presence of a tracheotomy tube or airway obstruction necessitating a tracheotomy tube.
• A documented history of noncompliance with recommendations to take nothing by mouth.
• Patients with an insensate larynx. Laryngeal sensation will be assessed with laryngopharyngeal sensory testing. An insensate larynx is defined as a laryngopharyngeal sensory threshold < 6 mmHg air pulse pressure or a complete absence of the laryngeal adductor reflex on palpation of the arytenoid with a flexible laryngoscope.
• Patients with a current, at the time of evaluation, and/or history of Zenker's diverticulum.
• Patients with sialorrhea at the time of evaluation with or without oral commissure incompetence.
• Patients with profound xerostomia at the time of evaluation.
• Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation.
• 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.
• 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, over-the-counter non-steroidal anti-inflammatories, herbal agents, and warfarin, etc.) that cannot be temporarily stopped for the procedure.
• 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.
• Patients taking antifibrotic medications.
• Patients with bilateral vocal fold immobility in any position, as evidenced on endoscopy.
• Patients with unilateral vocal fold immobility and unable to attain complete glottic closure, as evidenced on endoscopy.
• Patients with current, at the time of evaluation, and/or documented history of subglottic stenosis, as evidenced on endoscopy.
• Patients with current, at the time of evaluation, and/or documented history of airway obstruction, as evidenced on endoscopy.
• Patients with a life expectancy < 2 years.