Clinical trial: Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients (NCT02296528)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? Contradiction