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

The purpose of this study is to evaluate if the SED can safely and effectively improve
swallowing. Many people with severe swallowing disability (dysphagia) cannot open their upper
esophageal sphincter, which is a circular band of muscle that acts like a valve, allowing
food to enter the esophagus (food pipe) and go down into the stomach. People with extreme
dysphagia may cough and choke on food, liquid, and even their own saliva. These people are
always at risk of food/liquid/saliva accidently entering their lungs. This can cause
pneumonia and, in some cases, death. The SED was developed by the University of California,
Davis, to improve swallowing. The idea for the SED began when 6 people, who had feeding tubes
for 100% of their nutrition because of severe swallowing disability, had a long suture thread
attached to their throat. Patients pulled the two ends of the suture thread forward and were
able to open their upper esophageal sphincter. In fact, their swallowing improved so much
that 3 patients went home with the suture in place so that they could eat by mouth.
Unfortunately, the skin around the suture became red and painful within 2-9 days of use. The
suture was removed, but the idea for the SED was born. Since the suture study, three
different models of the SED have been developed, with each subsequent model better able to
improve swallowing, patient safety and use with other common medical tests. The current SED
model looks like the letter "T" or a office tack used to stick paper on a wall or board. The
SED has a plate and a post. The plate is like the top part of the "T" or smooth part of the
tack. The plate is attached to the cartilage or flexible connective tissue of the throat. The
SED post is like the bottom part of the "T" or pointy part of the tack, but instead of ending
with a point, the end has a small ring. The post permanently sticks out from the throat, like
a skin piercing, after the neck skin heals over the plate. Healing takes about 8 weeks. The
SED is made out of titanium because this metal is extremely strong and commonly used in
medical devices put into the body, such as hip joints or bone plates. A person can eat with
the SED by having food enter their esophagus when the SED post is pulled forward with their
fingers on the ring. Both sheep and human cadaver studies have shown that the SED works
extremely well to widely open the upper esophageal sphincter. The University of California,
Davis, and the United States Food and Drug Administration (FDA) have determined that the SED
is ready to be tested in a small human study.

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.