Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients With Life-threatening Aspiration Secondary to Feeding Tube Dependent Oropharyngeal Dysphagia: A Single-site, Open-label, Phase 1 Human Trial
Phase: NA
Conditions: Oropharyngeal Dysphagia (OPD), Dysphagia
Sponsor: Peter Belafsky, MD

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1) 
Protocol Title 
“Safety and Efficacy of the Swallow Expansion Device (SED) for 
Improvement of Swallowing in Patients with Life-Threatening Aspiration 
Secondary to Feeding Tube Dependent Oropharyngeal Dysphagia: A 
Single-Site, Open-Label, Phase I Human Trial” 
2) 
Author of Protocol 
 
UC Davis Research Investigator: Dr. Peter Belafsky, MD, MPH, PhD 
 
3) 
IRB Review History 
This application has been reviewed as IRB ID 390418-1. However, due to 
the time lapse, we are resubmitting it as for an initial review. 
4) 
Objectives 
DESIGN:  A single-center, open label, Phase I human trial 
DURATION: The initial feasibility study will be 2 years with 5 patients. 
The FDA has indicated that based on the safety results of this initial study, 
we may request an expansion of the study to 20 patients. 
POPULATION: The first 5 subjects of the initial feasibility study will be limited to 
adult patients with profound feeding tube dependent oropharyngeal dysphagia 
(OPD) of at least 12 months duration.  All patients will be at risk for life threatening 
aspiration and pneumonia due to the inability to tolerate any food safely by mouth 
and recruited from the clinical practices of the investigators at the Center for Voice 
and Swallowing, Department of Otolaryngology, University of California, Davis. If 
the FDA approves expanding the study, then 15 more subjects will be added. 
 
HYPOTHESIS: The swallow expansion device (SED) will be safe and efficacious 
for individuals with aspiration and profound oropharyngeal dysphagia (OPD). 
 
PRIMARY OBJECTIVE: Characterize the safety of the SED. Any implant 
infection, cricoid cartilage damage, implant rejection necessitating removal or other 
signs of irritation or injury will be noted. 
SECONDARY OBJECTIVES:  Characterize the efficacy of the SED by evaluating 
upper esophageal sphincter (UES) opening, swallowing safety, and dysphagia-
specific quality of life following implantation of SED. 
 
5) 
Background 
 
High Prevalence of Oropharyngeal Dysphagia (OPD) 
The three primary functions of the larynx are airway protection, respiration, and 
phonation (Tucker, 1987). If the larynx is unable to provide adequate airway 
protection during deglutition or the pharynx is unable to provide adequate bolus 
transit through the upper esophageal sphincter, oropharyngeal dysphagia (OPD) 

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ensues. Causes of OPD include stroke, head and neck cancer, head injury, 
advancing age, cricopharyngeus muscle dysfunction, amyotrophic lateral sclerosis, 
pseudobulbar palsy, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, 
muscular dystrophy and myasthenia gravis. OPD adversely affects approximately 
30% of all hospitalized patients (Altman, 2010), 75% of individuals in nursing 
homes (Spieker, 2000) and 78-81% of patients post-stroke (Martino, 2005). 
Epidemiological studies suggest that dysphagia also impacts 22% of all adults 50 
years or older and most individuals by 80 years of age (Howden, 2004). Concurrent 
chemoradiation for head and neck cancer is associated with a 45% incidence of 
prolonged feeding tube dependent OPD and an incidence rate for aspiration of 59% 
(Nguyen, 2004; Nguyen, 2006). The incidence of swallowing difficulties in persons 
with Parkinson’s disease is nearly 100% (Rosenbek, 2009). Despite the high 
prevalence of dysphagia, current treatment options are limited and millions of 
people remain disabled. 
 
Impact of OPD 
The impact of OPD on quality of life, morbidity, mortality, and health care 
expenditure is significant. In a survey of nasopharyngeal cancer survivors, 
dysphagia was the most important predictor of diminished quality of life (Lovell, 
2005). Elevated anxiety and depression are associated with dysphagia in head and 
neck cancer patients (Nguyen, 2006). Dysphagia in persons after total laryngectomy 
is associated with markedly increased social isolation, significantly impaired global 
functioning, depression, and anxiety, and in the general population, dysphagia is 
associated with depression and reduced general health (Eslick, 2008; Maclean, 
2009). Dysphagia is also associated with the feeling of helplessness, and the 
majority of persons with OPD believe that their condition is untreatable (Ekberg, 
2002). Complications of dysphagia include aspiration, dehydration, pneumonia, 
malnutrition, depression, and death. The dysphagia-specific mortality rate in 
persons treated with chemoradiation for head and neck cancer is 9% (Nguyen, 
2006). Aspiration pneumonia is one of the most common causes of death after 
stroke and is the most common cause of death in persons with Parkinson’s disease 
(Schmidt, 1994; Rosenbek, 2009). Of the 77 million hospitalizations in the U.S. in 
2004-2005, the adjusted mortality rate associated with OPD was 13.7, and hospital 
stays associated with dysphagia were twice as long as those for nondysphagic 
patients, representing a cost per year in the U.S. of $547 billion (Altman, 2010). 
Because of the high economic cost of OPD, the significant impact of OPD on 
quality of life, and the associated morbidity and mortality, improved recognition 
and treatment of this disorder are warranted. 
 
Treatment Options for Profound OPD are Severely Limited 
For persons with OPD, current treatment options include diet modification, 
swallowing therapy, intraoral prosthetics, non-oral feeding and invasive surgery. If 
a comprehensive dysphagia assessment with videofluoroscopy or nasoendoscopy 
reveals difficulty with certain food consistencies, dietary restrictions may be 
recommended or food rheology may be manipulated. Depending on the individual 
needs and the cognitive ability of the patient, swallowing therapy may include 

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exercise, sensory enhancement, postural changes, transcutaneous electrical 
stimulation, and swallowing maneuvers (Blumenfeld, 2006; Logemann, 2008; 
Mepani, 2009). Dental prosthetics may be employed to restore function to defects 
of the palate and tongue. If conservative management is unsuccessful in mitigating 
OPD, surgery may be considered. Surgical procedures shown to improve 
swallowing function in certain individuals with OPD include esophageal and upper 
esophageal sphincter dilation, cricopharyngeus muscle botulinum toxin injection, 
cricopharyngeus muscle myotomy, medialization laryngoplasty, arytenoid 
adduction, laryngohyoid suspension, pharyngoplasty, epiglottopexy, lateral 
thyrolaminectomy, great auricular to superior laryngeal neurorrhaphy, 
diverticulectomy and diverticulotomy in patients with a hypopharyngeal 
diverticulum, vocal fold closure, laryngotracheal separation, and total 
laryngectomy. The aim of these operations is to improve laryngopharyngeal 
sensation, airway protection, and upper esophageal sphincter opening. Regardless 
of our best efforts, these treatments fail in a significant percentage of individuals.   
 
Rationale for Study 
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 assist with 
the act of deglutition. We have developed a biomedical device (Swallow Expansion 
Device, SED) that assists with swallowing by mechanically opening the upper 
esophageal sphincter and allowing food and liquid to safely enter the esophagus. 
The SED has proven safe in cadaver and live animal studies (Belafsky, 2010). A 
Phase I, feasibility human trial is indicated to move the SED forward and improve 
the care of patients with OPD. 
 
6) 
Inclusion and Exclusion Criteria 
 
Screening 
All individuals will be provided with a patient brochure describing the study and 
will have signed the consent form before enrollment screening. After signing the 
consent form, the potential candidate will be asked about their demographics (age, 
date-of-birth). Physical characteristics will be collected, such as weight, height, pain 
scale, and breathing scale. Information on the individual’s present and past medical 
history as well as medication history will be collected. A general physical 
examination will be performed. A serum or urine -HCG (urine test must have a 
sensitivity of 25-50 mIU/mL) pregnancy test will be given to those women within 
childbearing age to confirm that they are not pregnant. 
The potential subject will receive a fluoroscopic swallow study to ensure 
profound OPD, diminished UES opening (< .55 cm for individuals under 65 
years of age, < .40 cm for individuals over 65 years of age), and an inability 
to tolerate any food safely by mouth. Potential subjects will also an 
endoscopy to determine laryngeal sensory threshold (< 6 mmHg air pulse 
pressure or a complete absence of the laryngeal adductor reflex on palpation 

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of the arytenoid with a flexible laryngoscope). Swallowing safety will be 
assessed with the Penetration Aspiration Scale (PAS: score of 5-8 indicates 
severe swallowing disability).  
The potential subject will complete the following assessments: 1) 
Abbreviated Mental Test Score (AMTS) to assess cognition, 2) Block and 
Box Test (BBT) to assess manual dexterity (ability to grasp the SED post), 
and 3) dysphagia specific quality of life instrument, the 10-item Eating 
Assessment Tool (EAT-10). The potential subject must demonstrate that 
they have the physical strength to pull the SED post forward, as evidenced 
by the ability to lift a 5-pound weight off of a table and keep it elevated for 
10 seconds. The 5 lb weight criteria is based on previous patient experience 
in which patients were able to control swallowing on their own with a suture 
by opening the upper esophageal sphincter with a mean pound-force of 4.18 
(± 0.68) (Belafsky, 2010).  
Inclusion Criteria  
 
1) Profound oropharyngeal feeding tube dependent dysphagia of greater than 12 
months duration, as documented by the prevalence of aspiration on 
fluoroscopic swallow study. 
2) Must be receiving 100% of nutritional requirements by enterogastric tube. 
3) 18 years of age and older, acceptable forms of documentation for verification 
of age include birth certificate, passport, and/or driver’s license. 
4) Diminished UES 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. 
5) Failure of > 3 months of dysphagia therapy within 3 months of study 
enrollment. 
6) No documented history of noncompliance with feeding recommendations. 
7) Cognition that is within normal limits, as evidenced by an Abbreviated Mental 
Test Score (AMTS) score greater than 6.  
8) Manual dexterity that is within normal limits for age, sex, and hand, as 
evaluated by a Block and Box Test (BBT).  
9) 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.  
10) 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. 
11) Bilateral vocal fold mobility or unilateral vocal fold immobility in which the 
individual is able to attain complete glottic closure as evidenced on 
endoscopy. 

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Exclusion Criteria 
 
1) Profound oropharyngeal feeding tube dependent 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) Able to safely consume any food or liquid by mouth, as documented by 
fluoroscopic swallow study. 
4) 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. 
5) 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).  
6) 17 years of age and younger, acceptable forms of documentation for 
verification of age include birth certificate, passport, and/or license. 
7) Success full receipt of dysphagia therapy or  < 3 months of dysphagia therapy 
within 3 months of study enrollment. 
8) 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. 
9) Inability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds.  
10) 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. 
11) Active tumor involving the cricoid or laryngeal cartilage. 
12) Known allergic reaction to titanium as evidenced by personal history of 
allergic or adverse reaction to titanium. 
13) Infection of cartilage, head, and/or neck at time of evaluation and/or 
implantation as documented by recent imaging study or abnormal physical 
examination. 
14) Presence of a tracheotomy tube or airway obstruction necessitating a 
tracheotomy tube.  
15) A documented history of noncompliance with recommendations to take 
nothing by mouth.  
16) 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 

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complete absence of the laryngeal adductor reflex on palpation of the 
arytenoid with a flexible laryngoscope.  
17) Patients with a current, at the time of evaluation, and/or history of Zenker’s 
diverticulum.  
18) Patients with sialorrhea at the time of evaluation with or without oral 
commissure incompetence. 
19) Patients with profound xerostomia at the time of evaluation. 
20) Patients with orocutaneous or pharyngocutaneous fistualae at the time of 
evaluation. 
21) 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. 
22) 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 anti-inflammatories, herbal agents, and warfarin, etc.) that cannot be 
temporarily stopped for the procedure. 
23) 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. 
24) Patients taking antifibrotic medications. 
25) Patients with bilateral vocal fold immobility in any position, as evidenced on 
endoscopy. 
26) Patients with unilateral vocal fold immobility and unable to attain complete 
glottic closure, as evidenced on endoscopy. 
27) Patients with current, at the time of evaluation, and/or documented history of 
subglottic stenosis, as evidenced on endoscopy. 
28) Patients with current, at the time of evaluation, and/or documented history of 
airway obstruction, as evidenced on endoscopy. 
29) Patients with a life expectancy < 2 years. 
Adults unable to consent, individuals who are not yet adults (infants, 
children, teenagers), pregnant women, and prisoners are excluded. 
If all inclusion criteria and screening assessments are satisfied (and exclusion 
criteria are negative), the potential subject will be asked to enroll in the study. 
  
Table 1: Patient assessments, frequency, and criteria 
Tests and evaluations 
Frequency 
Scale / assessment criteria 
EAT-10 survey 
Prior to SED 
Dysphagia specific quality of life 

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implantation 
will be assessed with the Eating 
Assessment tool (EAT-10). The 
EAT-10 is a validated self-
administered disease specific 
quality of life instrument for 
dysphagia.  EAT-10 survey results 
over the course of the study are a 
secondary endpoint. 
Month 6  
2 years (end of study) 
Abbreviated Mental Test Score 
(AMTS) 
Prior to SED 
implantation 
A score of > 6 is required for study 
inclusion. 
Block and Box Test (BBT) 
Prior to SED 
implantation 
A score within the normal limits 
per age, sex, and hand is required 
for study inclusion. 
5 pound weight lift 
Prior to SED 
implantation 
The ability to hold the weight off 
the table for 10 seconds is 
required for study inclusion. 
Laryngopharyngeal sensory 
threshold 
Prior to SED 
implantation 
A threshold of < 6mmHg air pulse 
pressure is required for study 
inclusion. 
Fluoroscopic swallow 
evaluation 
Month 2 
Results over the course of the 
study will be evaluated as primary 
and secondary endpoints. 
2 years (end of study) 
Determination of 8 point 
Penetration Aspiration Scale 
(PAS) 
Month 2 
0 = indicates a safe swallowing 
1-2 = indicates mild swallowing 
disability 
3 – 5 = moderate swallowing 
disability 
5 – 8 = severe swallowing disability 
[results over the course of the 
study are a primary safety 
endpoint]. 
 
7) 
Number of Subjects 
The total number of subjects to be enrolled locally for the initial feasibility 
study, N=5.  Expanded study, N=20 (add 15 more subjects to study). 
 
8) 
Recruitment Methods 
a) Local: 
Initially, 5 subjects will be recruited from the clinical practice of the 
Investigator (UC Davis Department of Otolaryngology, 2521 Stockton Blvd., 
Sacramento, CA). The patient population will include all individuals with 
chronic (>12 months) tube-dependent OPD who have failed traditional therapy 
and available surgical options. They will all be at risk for life threatening 
aspiration and pneumonia as determined by previous fluoroscopic swallow 

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assessment. All patients must possess the cognitive ability and manual dexterity 
to pull the device forward during swallowing. Although the majority of persons 
with profound tube-dependent OPD are > 50 yrs of age, there is no 
contraindication based on age, gender, race, or socioeconomic status. The study 
will be limited to adults 18 years of age and older.  
 
Once a candidate for study entry has been identified, the Investigator or Co-
Investigator will carefully explain the details of the study, and the candidate will 
be given a brochure describing the SED. If subjects are interested in the study, 
they will go through the informed consent process at the Department of 
Otolaryngology Voice and Swallowing Center (6th floor of Glassrock Building). 
During this process, they will be given a copy of the UC Davis Permission to 
Take Part in a Human Research Study form, which describes the study, and the 
Experimental Subject’s Bill of Rights to review with research study personnel. 
Subjects are encouraged to ask any questions/voice concerns.  If and when the 
subject consents, they will be asked to sign and date the informed consent form, 
Bill of Rights form, and HIPAA Authorization form, of which they will then 
receive signed and dated copies.  Subjects will next undergo screening. 
 
b) HIPAA: 
A waiver of HIPAA will be submitted for screening and/or recruitment 
procedures. The screening procedures pose no more than minimal risk to 
the participants. The participant’s rights and welfare will not be 
adversely affected by waiving consent. The waiver is needed to conduct 
records research to find potential patients that fit the inclusion / 
exclusion criteria, which fits the HIPAA Privacy Rule “preparatory to 
research provision.” 
This study involves the collection of PHI for recruitment purposes. Identifiers 
collected are name, date of birth, and medical record. The data will be stored 
electronically on an established database that is secure, password protected, and 
currently IRB-approved for the Department of Otolaryngology. Only 
investigators listed on the protocol will have access to the database. 
 
Data sheets used in the collection of PHI and generation of the recruitment 
database will be destroyed upon completion of the recruitment process. No data 
will be disclosed from the study.  
 
We assure that the protected health information will not be reused or disclosed 
to any other person or entity, except as required by law, for authorized oversight 
of the research study, or for other research for which the use or disclosure of 
protected health information for which an authorization or opportunity to agree 
or object is not required by 45 CFR 164.512. 
 

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9) 
Compensation to the Subjects 
 
Subjects will not be compensated. 
 
10) Study Timelines 
 
The initial feasibility study will be 24 months with 5 patients. The study will be 
expanded to 20 patients pending FDA approval of the safety results of the initial 
feasibility study. The estimated date of study completion is 2 years after the final 
subject is implanted with the SED.  We estimate 1-3 months for data analysis, 
depending upon whether the study population is 5 or 20 patients.

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Table 2: Schedule of Events by Time 
Time Prior to SED Implantation 
Day 0 
 
Day 1 
Week 1 
Weeks 
3, 
5, & 7 
Week 8 
(Month 2) 
Months 
3 - 5 
Month 
6 
Months 6 
-23 
Months 24 
(2 yrs) 
Event 
Fluoroscopic swallow 
evaluation (UES opening) 
SED 
surgery in 
out-patient 
clinic 
Follow-
up 
phone 
call 
Follow-
up clinic 
visit 
Follow-
up clinic 
visit 
Follow- 
up clinic visit 
Monthly 
follow-up 
clinic visits 
Follow- 
up clinic 
visit 
Monthly 
follow-up 
clinic visits  
.  
Follow-up clinic 
 visit 
Penetration Aspiration 
Scale (PAS) 
Laryngo-pharyngeal 
sensory threshold 
Fluoroscopic 
swallow 
evaluation 
(UES opening) 
EAT-10 
survey 
 
EAT-10 survey 
 
Abbreviated Mental Test 
Score (AMTS) 
Fluoroscopic 
swallow 
evaluation (UES 
opening) 
Block and Box Test (BBT) 
Skin 
suture 
removal 
Penetration 
Aspiration 
Scale (PAS) 
EAT-10 survey 
 
Penetration 
Aspiration Scale 
(PAS) 
Lift a 5 lb weight off a table 
and hold for 10 seconds 
Dietary 
changes  
 
Surgical removal 
of SED 

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11) Study Endpoints 
The primary objective of the experiment is to characterize the safety of the SED. Any 
implant infection, cricoid cartilage damage, implant rejection necessitating removal or 
other signs of irritation or injury will be noted at each monthly clinical visit and over the 
course of the study and recorded on the case report form.  
 
The secondary objective of the study is to characterize SED efficacy as defined by UES 
opening, swallowing safety (Penetration Aspiration Scale: PAS), and dysphagia-specific 
quality of life (EAT-10).  
 
For evaluation of both UES opening and swallowing safety (PAS), all measurements will 
be made from a de-identified pre-recorded digital video presented in random order at the 
end of the last time point to two investigators fully masked to SED use and time of 
recording (before SED implantation, and 2 months and 2 years post-SED implantation). 
Fluoroscopy trials will be digitally recorded using a Sony MD-1000 DVD recorder (Sony 
Corp. of America, New York, NY) and imported into ImageJ 1.41 for the Macintosh 
(National Institute of Health, Bethesda, MD). 
 
UES opening will be measured via fluoroscopy. Our quantitative assessment has been 
previously reported but will be briefly described (Leonard, 2006; Leonard, 2008a; Leonard, 
2008b). A digital still image will be captured at the point of maximum UES opening with 
and without anterior traction of the SED. The software will be calibrated to the known 
length of the SED that is visible in the fluoroscopic image. The distance between the 
anterior and posterior pharyngo-esophageal segment at the point of maximum UES opening 
will be calculated using analysis software with ImageJ.  
 
Swallowing safety, a measure of swallowing efficacy, will be assessed with the Penetration 
Aspiration Scale (PAS), a validated measure of swallowing safety determined on 
videofluoroscopy (Ludlow, 2007). A score of 1 indicates a safe swallow (material does not 
enter the airway). A score of 2-3 indicates mild, 4-5 moderate, and >5-8 severe swallowing 
disability (material enters the airway, it passes below the vocal folds, and no effort is made 
to expel it). The patient is initially fed a 1 cc bolus of thin barium. If no aspiration is 
detected, the patient is then administered a 3 cc and then 20 cc bolus, or largest bolus 
possible, of barium. If any aspiration is detected at any stage of the study, the procedure is 
terminated immediately. The PAS will be calculated for the largest swallowed bolus size 
on fluoroscopy.  
 
Dysphagia specific quality of life will be assessed with the Eating Assessment tool (EAT-
10). The EAT-10 is a validated self-administered disease specific quality of life instrument 
for dysphagia (Belafsky, 2008). The EAT-10 will be administered prior to device 
implantation, 4 months after use of the device (6 months after implantation), and at 2 years 
after device implantation. 

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12) Procedures Involved 
Device Implantation: 
Once enrolled in the study, the patient will be scheduled for surgical implantation of the 
SED, which will be performed at the UC Davis Swallowing Center outpatient operating 
room. Before the surgery, the patient will receive pre-operative clearance from the 
anesthesia service as well as appropriate pre-operative prophylactic antibiotics with 1g 
Cefazolin delivered intravenously. Immediately before the procedure, the patient will be 
given intravenous sedation, which is achieved with a combination of appropriate doses of 
Versed and Fentanyl, per continuous anesthesia monitoring. 
 
Once under sedation, the patient will be placed in the supine position with a shoulder roll. 
The neck will be prepped and draped in the usual sterile fashion. A combination of 
anesthetic and vasoconstrictor agent (2% lidocaine, two 1:100,000 units of epinephrine) 
will be injected into the incision site and underlying soft tissue and strap muscles. A 4 cm 
incision will be made in a cosmetically appealing skin crease 3 cm below the level of the 
cricoid cartilage. The subplatysmal skin flaps will be elevated, and the strap muscles 
divided in the midline. The cricoid will be identified, and the SED will be secured to the 
anterior rim of the cricoid with five 2-0 prolene sutures. The wound will be irrigated with 
antibiotic impregnated irrigation and the strap muscles closed over the SED. The SED post 
will be brought out through the skin at the level of the cricoid cartilage 3 cm above the 
incision. The skin will be closed in two layers with suture and/or surgical staples. 
Antibiotic ointment will be applied to the incision.  Before discharge, the patient will be 
instructed in local wound care. They will also be kept on 500 mg Cefazolin administered 
per their existing PEG tube 4X daily for 10 days.  
 
Immediately Post-Implantation: 
Immediately following surgery, each patient will be given post-surgery care instructions, 
“Patient Instructions For Use”, and a medical wallet card with emergency contact 
information. Each patient will be called on the first postoperative day to ensure that the 
patient is doing well and to monitor for any adverse events. If there is any indication of an 
adverse event, the patient will be seen immediately in the clinic. The patient will otherwise 
return to the clinic one week after device implantation. The skin sutures will be removed, 
and the incision will be evaluated for any signs of infection or implant rejection. The 
patient will be instructed on how to daily care for and clean the device and will return to 
clinic for an evaluation three, five, and seven weeks post-surgery. The patient will be told 
to not use the device or eat or drink anything by mouth until two months (week 8) after 
device implantation and only after physician evaluation and approval because the device 
could become loose or infected and need to be removed.  
 
Two Month Post-Implantation Evaluation for Use: 
Two months post-implantation, the patient will return to the clinic for a fluoroscopic 
swallowing evaluation with and without anterior traction on the SED. If swallowing is 

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improved and there is no aspiration, the patient will be taught how to coordinate pulling the 
SED with the correct amount of force at the appropriate time during swallow. Initial 
experience with a suture in humans suggests that patients readily adapt to manual control of 
the UES (Belafsky, 2010). There will be an initial training period in which a patient is 
instructed to do a limited number of pulls (1st week: 10 pulls / meal; 2nd week: 20 pulls / 
meal; 3rd week: 30 pulls / meal; 4th week: 40 – 50 pulls / meal). Patients will then be able to 
use the SED ad lib. If the SED is not approved for use in the patient, it will be removed. 
 
The rationale for limiting the number of pulls initially is to slowly and safely build up 
proficiency with the device. Under mechanical testing, the SED post-to-plate weld 
withstood up to 1,096,00 cycles of 6.3 pounds of pull force. This calculates to a life 
expectancy of 5 years when used 600 times per day, the normal number of swallows per 
day (John Hopkins, 2013).  We feel that this is an adequate safety factor considering that it 
is more than double the length of the 2-year study, which at the end, the SED will be 
removed and the fact that the SED is designed to use while eating, not while spontaneous 
swallowing. It expected that subjects will use a pull force less than that used in the 
mechanical testing; in a 6-patient study where sutures were placed around the cricoid 
cartilage and the patients manually pulled on the sutures, the patients were able to control 
swallowing on their own by opening the upper esophageal sphincter with a mean pound-
force of 4.18 (± 0.68) (Belafsky, 2010).  This is approximately 2 lbs less than the 
mechanical testing. 
 
In order to monitor the number of pulls, the physician will give the patient a monthly 
calendar form and hand clicker to record the number of pulls per meal. The total number of 
pulls / day will be recorded. Besides ensuring safety monitoring of the number of pulls, the 
forms will allow a record of progress with time. Calendar forms will be reviewed and 
provided at each monthly clinic visit. 
 
Patients will receive instruction on steps to take if the SED post breaks or the device 
malfunctions.  These include the following: 1) Immediately stop using the device, 2) Keep 
the area clean and dry, 3) Call the emergency physician telephone number listed on the 
patient wallet card; 4) If there is any bleeding, pain, fever or symptoms of breathing 
difficulty, go immediately to the nearest emergency room or call 911, and 5) If a piece of 
the device breaks off, place it in a bag and bring it to your doctor. In addition, the IRB and 
FDA will be notified of any adverse event, and it will be recorded on the case report form 
and on a separate Adverse Event Form. 
 
Monthly Follow-Up Visits: 
At each monthly follow-up visit, subjects will be evaluated for and questioned about 
overall health, secretion management, current diet, dysphagia symptoms, pulmonary status, 
pain, safety concerns, and changes in medical status. The physical appearance of the 
implant site will be evaluated for infection, cartilage damage, injury/irritation, infection, 
and implant rejection to determine SED safety.  Subjects will be weighed to ensure proper 

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nutrition and asked to bring in their monthly record of SED pulls per day.  Any concerns or 
necessary dietary adjustments will be addressed at this time. It is hoped that a patient will 
use the SED to such an extent that they can eventually enjoy most of their food via 
deglutination.  However, even if a patient has limited use of the SED and must rely on the 
majority of nutrition/hydration delivered via feeding tube, the very act of swallowing is 
beneficial as it improves oral hygiene (flushing out bacteria, saliva) and stimulates 
oropharyngeal muscles and nerves.  
 
If there are signs of irritation or injury to the implant site or if the patient complains about 
discomfort due to SED use, the patient will be instructed on how to modify the number of 
SED pulls per day and care for the implant site.  Follow-up calls to the patient will be made 
to determine if there is improvement. If there is no change, the patient will be told to return 
to the clinic. If there is improvement, the patient will be instructed on how to continue their 
course of SED use and will be re-evaluated at the next follow-up clinic visit.  They will be 
told to contact the Voice and Swallowing Center at any time if they have problems or 
questions. If there are any signs of skin infection or implant rejection, the patient will 
receive appropriate antibiotics and wound care. If there is any sign of abscess or implant 
rejection, or any infection does not resolve with appropriate antibiotics, the device will be 
removed. This can be performed in the clinic or minor procedure room under local 
anesthesia.  Patients will undergo routine PEG maintenance and replacement as per routine 
care. 
 
If due to extenuating-circumstances the larynx and SED implant are to be removed together 
then both will be retained to further study how the device integrated into the laryngeal 
tissue.  Also during SED implant removal, photographs may be taken of the implant site in 
vivo and ex vivo.  Implant removal at the 24 month study period will be considered as part 
of the study, if the Implant is removed after the 24 month study period then any surgical 
procedure to remove it will be considered as part of standard of care. 
 
Patients will undergo a dynamic fluoroscopic swallow study and penetration aspiration 
scale (PAS) two months after the SED has been placed. They will be administered the 
EAT-10 four months after use of the device (6 months post-SED implantation).  These 
procedures are done to evaluate SED efficacy. 
Pending FDA review of the data at the 6-month post-implantation time point and FDA 
approval, the study will continue to 2 years post-implantation.  During this time, the 
monthly follow-up visits will continue to evaluate device safety. At month 24, patients will 
undergo final dynamic fluoroscopic swallow and PAS exams and EAT-10 survey. The 
patient will be scheduled to have the device removed at the completion of the study.   

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All clinical and laboratory information required by this protocol will be present in the 
source documents. Sites will refer to the Source Document Guidelines. All stated 
evaluations are to be recorded on the CRF and keyed into the database unless otherwise 
specified. 
 
13) Data Management and Confidentiality 
 
Power Analysis: 
Per FDA request, the initial feasibility study will be limited to 5 patients.  This number of 
patients will give limited power but provide essential data to evaluate SED safety. If the 
study is expanded to a sample size of 20 patients following FDA review, we will have at 
least 85% power to detect a 0.6 standard deviation improvement in safety and efficacy 
(approximately the equivalent of a shift from the median level to the 73rd percentile). We 
would have an 88% chance of seeing at least one example of any adverse effect such as 
infection that occurred in 10% or more of individuals with an SED implant. 
Data Analysis: 
Per FDA’s request, the initial feasibility study will include 5 patients. The cumulative 
incidence of SED implant infection or other complications, such as cricoid damage and/or 
implant rejection, related to the SED implant will be shown graphically by a Kaplan-Meier 
curve, and a six-month cumulative incidence of infection and complication will be 
estimated with 95% confidence intervals by a life-table approach. The same evaluation 
approaches will be used pending FDA approval of the study and expansion to 20 subjects 
for two-years. 
Mean UES opening, swallowing safety (PAS), and EAT-10 scores will be 
compared before and after placement of the implant by analysis of variance, treating 
examiner as a fixed effect and patient as a random effect to account for repeated 
measures. UES opening and PAS scores will be compared before and after anterior 
traction using analysis of variance as described above. All tests will be one-sided, as 
this study is designed for screening with interest only in detecting improvements in 
swallowing; tests will be at level 0.05, with Bonferroni correction for multiple 
comparison. Quality of life with the EAT-10 will be assessed at baseline, 6 months 
and at 24 months after device implantation.  Baseline and 24 month data will be 
available for FDA review of the initial feasibility study. 
Data collected will be stored in a locked file cabinet in the PI’s office and on a secure 
database accessible only by password in the Department of Otolaryngology, so that 
confidentiality is maintained.  Each participant will be given a de-identified alphanumeric 
code so that the data is not identifiable to the participant.  Any adverse reactions will be 
recorded, notified to the Investigator, IRB and FDA as appropriate. 
Dr. Belafsky will maintain the following records, which will be only available to the study 
team or upon request of the IRB or FDA: 

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a) All study subject records including signed informed consent forms, case report forms, 
and any supporting documentation, 
b) All correspondence including required reports, 
c) Records of shipment of the devices, 
d) Records of sterilization and receipt of devices, 
e) Records of disposition of a device, 
f) Signed investigator agreements including financial disclosure information, 
g) Records concerning complaints and adverse device effects whether anticipated or not,  
h) Any other records that the FDA requires to be maintained by regulation or by specific 
requirement for a category of investigation or a particular investigation. 
The researchers will keep all necessary data in the Department of Otolaryngology for no 
more than 10 years, at which time it will be destroyed. The data will be kept for this length 
of time so that it will be available for the FDA to review for future clinical studies and 
marketing approval of the SED. If information from the study is published or presented at 
scientific / educational meetings, names and other personal information will not be used.  
 
14) Provisions to Monitor the Data to Ensure the Safety of Subjects 
Study Monitors 
Drs. Peter Belafsky and Maggie Kuhn 
2521 Stockton Blvd, Ste. 7200, Sacramento, CA 95817 
 
The UC Davis Health System Clinical Trials Resource Group will also assist with 
monitoring and quality assurance through review of the clinical documents and data. The 
Group is housed on campus as part of the Clinical and Translational Science Center and 
ensures compliance with FDA, GCP, and IRB regulations, and UC Davis Health System 
SOPs and P&Ps as related to clinical research.  
Principal Investigator Responsibilities 
As PI, Dr. Belafsky, will be responsible that the following are carried out: 
 
• Ensure that the protocol is being followed 
• Ensure that changes to the protocol are approved by the UC Davis IRB  
• Ensure that accurate and complete records are being maintained by the site 
• Ensure that accurate and complete reports are being made to the sponsor and the 
UC Davis IRB 
• Ensure that the information in the investigator’s report is complete, accurate, and 
legible 

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• Ensure that there are no omissions in the reports of data that may be directly or 
indirectly relevant to the study 
• Ensure that missing examinations are noted in the reports 
• Ensure that subjects failing to complete the study are noted along with the reason 
for such failure 
• Ensure that informed consent is documented 
 
The study monitors will be responsible for ensuring that the investigative site is 
performing their duties as set forth above, and that the investigator understands the 
following: 
 
• Investigational status 
• Device accountability 
• Protocol 
• Obligation of regulatory requirements 
• IRB review and approval 
• Obtaining informed consent 
• Access to adequate number of subjects 
• Access to adequate facilities 
• Sufficient time to participate in the study and 
• How to use the device 
Dr. Belafsky will also provide the following reports in a timely manner to the UC Davis 
IRB and FDA to ensure the safety of the subjects: 
• 
Unanticipated Adverse Device Effects  
• 
Withdrawal of IRB Approval 
• 
Withdrawal of FDA Approval 
• 
Progress Reports 
• 
Recalls and Device Disposition 
• 
Final Report 
• 
Informed consent 
• 
Significant Risk Device Determination 
 
Reviewing Data, Auditing and Inspecting 
The initial feasibility study will be 24 months with 5 patients. The study will be 
expanded to 20 patients pending FDA review and approval of the safety results of 
the initial feasibility study. 
The investigator will permit study-related monitoring, audits, and inspections by the IRB, 
the sponsor, government regulatory bodies, and compliance and quality assurance groups 

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of all study related documents (e.g. source documents, regulatory documents, data 
collection instruments, study data etc.).  The investigator will ensure the capability for 
inspections of applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, 
etc.). Participation as an investigator in this study implies acceptance of potential 
inspection by government regulatory authorities and applicable compliance and quality 
assurance offices. 
 
15) Withdrawal of Subjects 
 
Subjects will be withdrawn from the study without their consent for the following reasons: 
Permanent Treatment Discontinuation 
 
• Abscess. 
• Implant rejection. 
• Infection does not resolve with antibiotics. 
• Requirement for prohibited concomitant medications (see exclusion criteria). 
• Pregnancy. 
• Completion of treatment as defined in the protocol. 
• Request by subject to terminate treatment. 
• Clinical reasons believed life threatening by the physician. 
• MRI imaging (SED removed if MRI is needed). 
Premature Study Discontinuation 
 
• Failure by the subject to attend 3 consecutive clinic visits. 
• Subject repeatedly noncompliant with study procedures, as prescribed. 
• Pregnancy or breast-feeding. 
• Request by the subject to withdraw. 
• Request of the primary care provider if s/he thinks the study is no longer in the best 
interest of the subject. 
• Any evidence of infection or injury not capable of being treated by local care and 
antibiotics. 
• Subject judged by the investigator to be at significant risk of failing to comply with 
the provisions of the protocol as to cause harm to self or seriously interfere with the 
validity of the study results. 
• At the discretion of the IRB, Food and Drug Administration (FDA), Office for 
Human Research Protections (OHRP), or investigator. 
Subjects will be scheduled for explantation of the SED. They will be provided 
with post-surgery instructions of care.  The event will be recorded on the two 

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following case report forms: Off-Study Form and Early Off-Study SED Removal 
Form.  
 
 

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16) 
Risks to Subjects 
Adverse Event Reporting  
 
An adverse event (AE) is any unwanted medical occurrence in a subject that does not necessarily have a causal relationship with the study 
intervention.  An AE can be any unfavorable or unintended sign, symptom, or disease temporarily associated with the use of a medical 
treatment or procedure regardless of whether it is considered related to the medical treatment or procedure. An adverse device effect (ADE) 
is a device-related AE.  
 
All AE's will be classified as anticipated, unanticipated, or serious. All potential hazards listed in the Risk Evaluation and Mitigation 
Strategies (Table 3) are considered “anticipated.” All events not listed in the Risk Evaluation and Mitigation Strategies are considered 
“unanticipated.” Expected events that occur with a greater frequency than expected are also considered “unanticipated.” A “serious” AE is 
defined as any untoward medical occurrence that meets any one of the following criteria: 
 
1. Results in death or is life-threatening at the time of the event 
 
2. Requires inpatient hospitalization, or prolongs hospitalization 
 
3. Results in a persistent or significant disability / incapacity 
 
4. Is a congenital anomaly / birth defect (in a participants offspring) 
5. Requires medical or surgical intervention to preclude permanent impairment of body function or damage to body structure based 
on suspected use of a medical device 
6. Is medically judged to be an important event that jeopardized the subject, and, for example, required significant measures to 
avoid one of the above outcomes 
 
AEs that occur during the study, whether considered device / procedure-related or not, will be recorded on the CRF Adverse Event Form 
and, ultimately, reported in the IDE study. The CRF AE form asks for AE description, start/stop date, outcome, severity, plausible 
relationship to the study device, action taken (including withdrawal), and AE classification. AE severity will be defined as mild (event that 
causes mild discomfort or inconvenience and resolves without treatment), moderate (event that requires medical intervention or medication 
to treat), or severe (event that requires intervention to prevent permanent impairment or damage, an event that requires or prolongs 
hospitalization, or an event that is disabling, causing permanent damage, life threatening, or causing death). Any necessary treatment or 
intervention required and the resolution status of the AE will also be documented. Each AE will be followed to resolution. If the AE 
presents an unreasonable risk to the to the subjects, the SED will be removed and the study terminated for the subject.   
 
Study personnel must notify the Investigator of any unanticipated or serious AE within 24 hours of learning about the event.  The investigator 

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will notify the IRB and FDA within 5 days of becoming aware of the AE.  
 
Table 3: Risk Evaluation (According to 21 CFR 812.25(c)) and Mitigation Strategies 
 
No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
1.  Surgical Procedure 
Pain 
The device is placed through a small, minimally 
invasive skin incision under intravenous sedation 
with anesthesia monitoring.  The patient will be 
brought into the UC Davis Swallowing Center 
outpatient operating room and placed supine. 
The neck will be prepped and draped in the 
usual sterile fashion. 
The implant is secured to the anterior rim of the 
cricoid cartilage five 2-0 prolene sutures.  The 
suture is placed through the implant and then 
around the anterior rim of the cartilage to 
anchor the device.  This technique has shown to 
be effective in securing the device safely in 
human cadavers and sheep. 
Pre-operative clearance from the anesthesia service; 
routine surgical sedation; crico-thyroid notch will be 
infiltrated with 2% lidocaine. 
2.  Surgical Procedure 
Bleeding 
Minimally invasive 4 cm skin incision 
3.  Surgical Procedure 
Infection 
Pre-operative prophylactic antibiotics with 1G 
Cefazolin. 
Prophylactic antibiotics administered per patients 
existing PEG tube for 10 days. 
4.  Surgical Procedure – suturing 
technique 
Effects on cricoid 
cartilage 
The implant is secured to the anterior rim of the 
cricoid cartilage with five 2-0 prolene sutures.  
Each suture is placed through the implant and 
then around the anterior rim of the cartilage to 
anchor the device.  Sutures are not placed 
through the cartilage, and no fixation with 
surrounding tissue is made.   
The surgical technique and placement of the 
device has shown to be effective in securing the 
device safely in human cadavers and sheep. 
Patient evaluation throughout the study per 
protocol and documented on Case Report Form 
(CRF). 

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No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
5.  Device dropped or deemed 
unsterile in some manner 
Delay or abort 
procedure 
There is no increased risk with this surgical 
procedure as with any other surgical procedure. 
(Flash sterilization will not be allowed) 
Additional sterile devices will be available to prevent 
procedure cancellation with minimal delay. 
6.  Device Plate 
Damage to 
vascular or neural 
structures 
Profound dysphagia is severely disabling.  
Patients are constantly coughing and choking on 
their own saliva and are at an enduring risk of 
aspiration and pneumonia and death.  Tube 
feeds are expensive and dehumanizing.  Patients 
become depressed and socially isolated.  The 
risks associated with implantation of the SED are 
outweighed by the potential gain in swallowing 
safety and quality of life improvement to the 
patient. 
This risk has been included on the patient consent 
form. 
7.  Device Plate 
Damage to the 
cricoid cartilage 
causing dyspnea 
This risk has been included on the patient consent 
form. 
8.  Device Post 
Infection at entry 
site 
Skin irritation 
Titanium is highly biocompatible, and titanium 
implants have precedent in head and neck 
surgery and are commonly used in traumatic 
and oncologic reconstruction. 
The post protrusion through the skin in a 
manner similar to a common body piercing. 
 
Pre-operative prophylactic antibiotics with 1G 
Cefazolin 
Prophylactic antibiotics administered per patients 
existing PEG tube for 10 days 
Healing per normal/usual body piercing 
ASTM F67-00, grade 2 - unalloyed titanium for 
surgical implant applications  
Endotoxin testing per ANSI/AAMI ST72, USP <161>, 
USP <85>, EP 2.6.14, JP 4.01 
Steam sterilized per ISO 17665-1:2006 

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No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
9.  Mechanical trauma – e.g., 
rolling over while sleeping 
Tearing of 
skin/cartilage 
Dislodging from 
cartilage 
Damage to 
esophagus 
The post protrusion through the skin in a 
manner similar to a common body piercing. 
Precaution included in the IFU. 
Patient wallet card has emergency Otolaryngology 
contact information. 
10.  
Lateral torque; anterior pull 
(unexpected) 
Mechanical trauma – e.g., 
getting clothes caught while 
dressing/undressing, caught 
on towel while drying 
Tearing of 
skin/cartilage 
Dislodging from 
cartilage 
Damage to 
esophagus 
The loop design provides a soft, blunt, fingertip 
sized surface to tactilely locate between the 
finger and thumb surfaces for the patient to 
hold onto.  The loop is thought to be less likely 
to catch onto clothing or blankets, with its 
smooth round design vs. a perpendicular bar 
that could allow looped threads to slip over 
either end of the bar.  The loop design has not 
shown any problems of this nature in testing 
conducted to date. 
Precaution included in the IFU. 
Mechanical integrity testing. 
Patient wallet card has emergency Otolaryngology 
contact information. 
11.  Severe mechanical trauma 
separating post from plate 
Device inoperable 
by patient 
Damage to 
esophagus 
The post protrudes through the skin in a manner 
similar to a common body piercing.  The small 
size of the plate and post length lends to it being 
highly improbable that sheer force can be 
applied at the right angle to separate the post 
from the plate. 
Weld inspection. 
Mechanical integrity testing. 
Precaution and instructions included in IFU. 
Patient wallet card has emergency Otolaryngology 
contact information. 
12.  
Severe mechanical trauma 
pushes post end back 
through skin - e.g., car airbag 
deployment; severe coughing 
Device inoperable 
by patient 
Skin injury, 
bleeding, pain 
Requires surgical 
intervention to 
relocate through 
appropriate exit 
The post protrudes through the skin in a manner 
similar to a common body piercing. 
Precaution included in the IFU. 
Patient wallet card has emergency Otolaryngology 
contact information. 

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No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
13.  Intended use of device – 
engaging post to open UES 
Weld fails, 
separating post 
from plate 
Swallowing dysfunction (oropharyngeal 
dysphagia: OPD) is common and costly.  The 
impact of OPD on quality of life, morbidity, 
mortality, and health care expenditure is 
significant.  The SED is intended to reduce the 
aspiration of saliva, allow for the oral 
consumption of food, and improve (transform) 
an individual’s quality of life. 
Weld inspection. 
Mechanical integrity testing. 
Precaution and instructions included in IFU. 
Patient wallet card has emergency Otolaryngology 
contact information. 
14.  Unintended use of the device  
- too much tension on post 
Dislodges plate 
from cartilage; 
tissue tears  
Healing occurs in eight weeks.  During this time, 
the Swallow Expansion Device (SED) plate 
becomes incorporated by a thick fibrous 
capsule, which ensures a strong integration with 
the cricoid cartilage. 
Mechanical integrity testing 
Precaution included in the IFU. 
Patient wallet card has emergency Otolaryngology 
contact information. 
15.  Unintended use of device - 
too little tension on post 
Upper esophageal 
sphincter (UES) 
under expanded, 
swallowing does 
not occur; 
aspiration 
Mechanical integrity testing 
Precaution included in the IFU and patient wallet 
card has emergency Otolaryngology contact 
information. 

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No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
16.  
Implanted device design – 
anatomy concerning: 
1. Mobility of cricoid 
cartilage during speech 
and swallowing; and 
2. Percutaneous placement 
of device 
Local wound 
infection 
Cartilaginous infections are difficult to manage, 
particularly those of the cricoid cartilage.  In 
addition, cricoid cartilage infections (chondritis) 
can lead to devastating complications of loss of 
cartilage and breathing difficulties from loss of 
cricoid cartilage stability. 
To minimize patient harm associated with infection, 
patients will be closely monitored every two weeks 
for the first two months after implantation.  They 
will then be monitored monthly until two years after 
device implantation.  Monitoring, besides visual 
examination by a physician, includes a pain scale 
and ease of breathing scale, both of which could be 
indications of adverse effects on the cricoid 
cartilage. 
Any sign of infection will be immediately treated 
with appropriate antibiotics.  The implant will be 
removed if there is any sign of infection that does 
not resolve with antibiotics or any sign of abscess 
formation, tissue or cartilage damage, or implant 
rejection.  
17.  Implanted device – corners or 
edges of plate 
Stress 
concentrations, 
tissue damage 
over time 
The Swallow Expansion Device (SED) plate 
becomes incorporated by a thick fibrous 
capsule, which ensures a strong integration with 
the cricoid cartilage. 
All edges of the plate have a rounded radius vs. 
square. 
Electro-polishing of finished device removes burrs 
that may be present; visual inspection. 
Mechanical integrity testing. 
18.  Implanted device 
Remodeling, 
deformation, 
chondritis 
The implant is secured to the anterior rim of the 
cricoid cartilage with five 2-0 prolene sutures.  
The suture is placed through the implant and 
then around the anterior rim of the cartilage to 
anchor the device.  This technique has shown to 
be safe and effective in securing the device in 
human cadavers and sheep. 
There was no histological evidence of chondritis 
or cartilage damage in our animal experiments. 
Patient evaluation throughout the study per 
protocol and documented on Case Report Form 
(CRF). 
Two years after implantation the study will be 
terminated and the implant will be removed.  The 
patients are under routine medical care for their 
condition, and the implant will be part of their 
history and on-going routine medical care. 

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No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
19.  Implanted device 
Device rejection 
As with any implant, there is a risk of implant 
infection and rejection.  Titanium is highly 
biocompatible.  Titanium implants have 
precedent in head and neck surgery and are 
commonly used in traumatic and oncologic 
reconstruction. 
This risk is included on the patient consent form. 
Device constructed from ASTM F67-00, grade 2 - 
unalloyed titanium for surgical implant application. 
To minimize patient harm associated with rejection, 
patients will be closely monitored every two weeks 
for the first two months after implantation.  They 
will then be monitored monthly until two years after 
device implantation.  The implant will be removed if 
there is any sign of infection that does not resolve 
with antibiotics or any sign of abscess formation, 
tissue or cartilage damage, or implant rejection.  
20.  Implanted device 
Inability to 
perform 
emergency 
tracheotomy or 
standard airway 
intubation 
Because the location of the implant is in close 
proximity to the location of a tracheotomy tube, 
this implant may be at an increased risk of 
becoming infected 
This risk has been included on the patient consent 
form. 
Precaution included in the IFU and patient wallet 
card. 
Removal of the device is recommended should a 
tracheotomy be required.  Removal of the device 
can be performed at the time of tracheotomy tube 
placement or at anytime before the procedure. 

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No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
21.  Implanted device 
Radiation exposure 
from fluoroscopic 
swallow study 
Impact from 
radiation therapy 
Subjects will be exposed to radiation when 
undergoing fluoroscopy.  Because fluoroscopy is 
a standard procedure in the Department of 
Otolaryngology to assess swallowing, it is 
already approved by the UC Davis Health 
System Radiation Use Committee and 
monitored by Radiation Safety Program at UC 
Davis. The potential risks from the Modified 
Barium Swallow (MBS) studies (evaluation) are 
negligible. MBS does involve some radiation to 
the neck. The exact amount of radiation varies 
with the time of exposure, settings and 
equipment used. One study in the literature 
reported a 5 minute MBS study delivers an 
effective dose of 0.4 mSv (40 mrem), which they 
stated was equivalent to 10 chest x-rays (Wright 
et al., Dysphagia, 1998. 13:113-115). Other 
sources have reported different levels of 
radiation. One of the Boston University co--
investigators had a physicist measure radiation 
exposure for 2 ½ minutes of MBS; the results 
were a whole body effective dose of 9 mrem. 
This would convert to only 18 mrem for a 5 
minute study. Moreover, the University of South 
Carolina Radiation Safety Office web site 
(http://www.musc.edu/fanda/risk/radiation) 
states that a chest x-ray yields 8 mrem, with a 
range of 3 to 20 mrem. Thus, it appears that the 
two examinations (the MBS and chest x-ray) are 
very similar in the level of radiation exposure.  
Thus, the risk of radiation exposure from a MBS 
is negligible.  
The effect of the device on radiation therapy to 
the neck is uncertain.  
This risk has been included on the patient consent 
forms. 
Should radiation therapy to the neck be required, 
we recommend removal of the device prior to the 
initiation of therapy. 
Precaution added to IFU for healthcare provider. 

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No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
22.  Implanted device 
Seroma 
Titanium is highly biocompatible and magnetic 
resonance imaging (MRI) compatible.  Titanium 
implants have precedent in head and neck 
surgery and are commonly used in traumatic 
and oncologic reconstruction. 
This risk has been included on the patient consent 
forms. 
23.  Implanted device 
Erosion 
This risk has been included on the patient consent 
forms. 
24.  Implanted device 
Allergic response 
This risk has been included on the patient consent 
forms. 
Device constructed from ASTM F67-00, grade 2 - 
unalloyed titanium for surgical implant application. 
25.  Implanted device 
Migration or 
loosening 
Based upon animal experiments, a 2-month 
waiting period prior to use of the device allows 
for a mature fibrous capsule to form.  This 
allows the device to become integrated onto 
the cricoid cartilage before patient use. 
This risk has been included on the patient consent 
forms and IFU. 
26.  Implanted device 
Pain – at implant 
site or while 
swallowing 
Profound dysphagia is severely disabling.  
Patients are constantly coughing and choking on 
their own saliva and are at an enduring risk of 
aspiration and pneumonia and death.  Tube 
feeds are expensive and dehumanizing.  Patients 
become depressed and socially isolated.  The 
risks associated with implantation of the SED are 
outweighed by the potential gain in swallowing 
safety and quality of life improvement to the 
patient. 
This risk has been included on the patient consent 
forms. 
Patient evaluation of pain scale (1-5) throughout the 
study documented on Case Report Form (CRF) 
Two months after implantation and prior to patient 
use, a fluoroscopic swallow evaluation will be 
performed with and without anterior traction on the 
device. 

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No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
27.  Implanted device 
Impaired 
swallowing 
The Penetration Aspiration Scale (PAS) is a 
validated measure of swallowing safety 
determined on video-fluoroscopy.  A score of 0 
indicates a safe swallow.  A score of 1-2 indicates 
mild, 3-5 moderate, and >5 indicates severe 
swallowing disability.  
This risk has been included on the patient consent 
forms. 
Two months after implantation and prior to 
physician approval of patient SED use, a fluoroscopic 
swallow evaluation will be performed with and 
without anterior traction on the SED. 
Swallowing safety will be assessed with the 
Penetration Aspiration Scale (PAS).  The PAS will be 
calculated from de-identified pre-recorded digital 
video for the largest swallowed bolus size on 
fluoroscopy before placement and two months 
after placement of the SED by an investigator 
without knowledge of the presence or absence of 
SED use. 
28.  Implanted device 
Security system 
activation – e.g. 
retail stores, 
airports 
Titanium is highly biocompatible.  Titanium 
implants have precedent in head and neck 
surgery and are commonly used in traumatic 
and oncologic reconstruction. 
This risk has been included on the patient consent 
forms.  Patient will have a wallet card. 

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No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
29.  MRI and/or CT 
incompatibility 
Misdiagnosis with 
imaging 
procedure; 
dislodging of 
device 
Titanium is highly biocompatible and magnetic 
resonance imaging (MRI) compatible.  Titanium 
implants have precedent in head and neck 
surgery and are commonly used in traumatic 
and oncologic reconstruction. 
We recommend that device be removed before MRI.  
Precaution added to IFU and patient wallet card. 
Plate and post constructed of ASTM F67-00, grade 2 - unalloyed 
titanium for surgical implant application. 
Report Evaluation of Magentic Field Interactions, Heating, and 
Artifacts at 3-Tesla for the Swallow Expansion Device (SED)  
▪ 
Magnetically induced forces and torques 
▪ 
Heating of the device produced by the magnetic and RF fields 
during imaging 
▪ 
Image artifacts produced from presence of device 
FDA Guidance – Establishing Safety and Compatibility of Passive 
Implants in the MR Environment 
ASTM F2052 Standard Test Method for Measurement of 
Magnetically Induced Displacement Force on Medical Device in the 
Magnetic Resonance Environment 
ASTM F2119 -07 Standard Test Method for Evaluation of 
MR Image Artifacts from Passive Implants 
ASTM F2182-11 Standard Test Method for Measurement of 
Radio Frequency Induced Heating Near Passive Implants 
During Magnetic Resonance Imaging 
ASTM F2503 Standard Practice for Marking Medical Devices 
and Other Items for Safety in the Magnetic Resonance 
Environment 
IFU includes: 
▪ 
MR field conditions (1.5T and/or 3T; open and/or cylindrical 
MR systems) 
▪ 
Spatial gradient 
▪ 
Displacement force 
▪ 
MR heating 
 

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No. 
Potential Hazard 
Resultant Harm 
Risk Evaluation Discussion 
Mitigation Strategy 
30.  
Image artifact or lack of 
artifact with CT (contrast and 
non-contrast), PET, nuclear 
medicine, ultrasound images 
of the thyroid. 
Misdiagnosis with 
imaging procedure 
Titanium is highly biocompatible and magnetic 
resonance imaging (MRI) compatible.  Titanium 
implants have precedent in head and neck 
surgery and are commonly used in traumatic 
and oncologic reconstruction. 
Should imaging of the neck be required, inform the 
healthcare providers about the implant prior to the 
procedure.  Should the patient’s physician 
determine the imaging procedure absolutely 
necessary, removal of the device prior to the 
initiation of the imaging procedure is 
recommended. 
Precaution included in the IFU and patient wallet 
card. 
31.  Endotoxins 
Adverse reaction 
Titanium is highly biocompatible.  Titanium 
implants have precedent in head and neck 
surgery and are commonly used in traumatic 
and oncologic reconstruction. 
Device labelled sterile 
Endotoxin testing per ANSI/AAMI ST72, USP <161>, 
USP <85>, EP 2.6.14, JP 4.01 
 

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17) Potential Benefits to Subjects 
 
Subjects may directly benefit from having improved swallowing. The improvement 
may be mild or significant. They may be able to better swallow their saliva. There is 
a possibility that they will be able to eat or drink some food or liquid once the 
device is implanted, which may benefit them psychologically, socially and 
nutritionally. Use of the SED may decrease the risk of aspiration and pneumonia. 
Even if a subject has limited use of the SED and must rely on the majority of 
nutrition/hydration delivered via feeding tube, the very act of swallowing is 
beneficial as it improves oral hygiene (flushing out bacteria, saliva) and stimulates 
oropharyngeal muscles and nerves.  
 
18) Sharing of Results with Subjects 
At the conclusion of the study, all results will be made available to the 
subjects.  
19) Setting 
All recruiting and procedures will be conducted at 2521 Stockton Blvd, 
Sacramento, CA 95817, where the Department of Otolaryngology is housed. 
Recruitment will occur in the Voice and Swallowing Center, and the surgery 
will occur in the Swallowing Center outpatient operating room. 
20) Resources Available 
Personnel 
Investigator, Dr. Peter Belafsky, MD, MPH, PhD: Dr. Belafsky's primary 
clinical interests are the comprehensive diagnosis and management of 
voice, swallowing, and airway disorders. As Medical Director of the 
Voice and Swallowing Center at UC Davis, Dr. Belafsky treats a wide 
array of laryngeal and esophageal disorders. These disorders include but 
are not limited to vocal fold paralysis and paresis, vocal fold dysfunction 
(VCD), laryngopharyngeal reflux (LPR), chronic cough, and dysphagia 
caused by stroke, ALS, Zenker's diverticulum, esophageal motility 
disorders, Parkinson's disease, and swallowing problems suffered as a 
consequence of the treatment of head and neck cancer. Dr. Belafsky has 
pioneered minimally invasive treatments of voice and swallowing 
disorders. As the primary investigator, Dr. Belafsky will be responsible for 
personally enrolling and consenting all subjects. He will also be the 
primary surgeon an all implant placements and will be responsible for 
patient follow-up, adverse event, and device monitoring. He will oversee 
data collection and will be responsible for data analysis.  
Co-Investigator, Dr. Maggie Kuhn, MD: Dr. Kuhn’s primary clinical 
interests are the evaluation and treatment of routine and complex disorders 
of voice, airway and swallowing.  As a fellowship-trained laryngologist, 
she has experience in caring for a broad spectrum of patient conditions.  

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These include hoarseness due to injury, neurogenic disease, malignancy, 
aging or misuse/overuse, dysphagia resulting from chronic disease, 
surgery, cancer treatment or cerebrovascular accident and dyspnea 
secondary to airway stenosis, vocal fold dysfunction or benign neoplastic 
disease. As the co-investigator, Dr. Kuhn will be responsible for assisting 
with device implantations, data analysis, and patient follow-up. 
Laryngology Fellow: Dr. Naren Venkatesan is a laryngology clinical 
fellow working under the direction of Drs. Belafsky and Kuhn.  He will be 
responsible for assisting Drs. Belafsky and Kuhn during the surgical 
implantations and will contribute to the data analysis and patient follow-
up. 
Clinical Research Coordinator: The clinical research coordinator will be 
responsible for organizing, oversight, and storage of all IRB consent and 
protocol forms. S/he will also assist with patient follow-up, device and 
adverse event monitoring, and will be responsible for data collection and 
storage. The CRC will need to well-versed in the conduct of clinical 
investigations involving humans, Good Clinical Practice, IRB and FDA 
regulations. 
Feasibility of recruiting subjects 
The FDA has approved the implantation of only 5 patients. The Division 
of Laryngology has a pool of suffering patients who have been waiting 
years for device implantation. The study participants will be chosen from 
this pool of existing patients. 
 
Study effort 
 
Dr. Belafsky will devote 5% effort to this project. Dr. Kuhn will similarly 
devote 5% effort to this project. The clinical trials coordinator will devote 
25% effort to this project. This will ensure more than adequate time to 
manage the enrolled subjects. 
 
Facilities 
The Otolaryngology Department is housed in the Glassrock Building on the main 
School of Medicine campus. The department owns and operates fluoroscopy 
systems, which in many hospital settings would be housed separately in 
Radiology. Clinic staff and investigators are thoroughly familiar with reading and 
interpreting fluoroscopic studies as the Center for Voice, Speech and Swallowing 
Center sees a high volume of patients yearly (400-500).  The Center maintains a 
large database of fluoroscopy studies from dysphagic patients. In addition, the 
Swallowing Center outpatient operating room is also located in the Glassrock 
Building.  
 
Medical / Psychological resources 

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A member of the research team (Dr. Belafsky or Dr. Kuhn) will be 
available by cellphone or pager 24 hours a day throughout the time of the 
entire study. The clinical trials coordinator will also be available daily 
throughout the study period. 
 
 
 
Study personnel communication 
 
A study kick-off meeting will be conducted before the initiation of the 
trial. Weekly meeting and communication between study personnel will 
occur every Wednesday afternoon at 4pm before the initiation of 
dysphagia conference. Daily communication will occur as needed to 
address adverse events or other study-related problems that arise.  
21) Prior Approvals 
The FDA has approved this IDE study providing that we obtain IRB 
approval.  The FDA has indicated that based on the safety results of an 
initial feasibility study of 5 patients for at least 6 months, we may request an 
expansion of the study to 20 patients.   
22) Provisions to Protect the Privacy Interests of Subjects 
Efforts will be made to limit use or disclosure of subject personal 
information, including research study and medical records, to people who 
have a need to review this information as per UCDMC policy on protecting 
patient information. We cannot promise complete confidentiality. 
Organizations that may inspect and copy subject information include the 
IRB, the U.S. Food and Drug Administration, and other University of 
California representatives responsible for the management or oversight of 
this study.  
Personal information about the subject will be coded so that their name will 
not be associated with any information pertaining to the results, 
publications, or presentations regarding this study.  All data and information 
will be maintained and stored securely (i.e., locked file cabinets, password 
protected computers, coded video and audio files) in the Department of 
Otolaryngology, University of California, Davis, so that confidentiality is 
maintained.  This consent form will be filed in an official area. People who 
will have access to the subject’s information will include the Investigator 
and research study personnel. The Investigator and study personnel will only 
access the data for research purposes.  
Subjects will be informed of the provisions to protect their privacy during 
the consent process, including all forms of written, spoken, and electronic 
personal and health information.  Subjects will told that they are free to ask 
any question about their privacy at any time.  All study procedures will take 
place in the privacy of medical offices / rooms.  

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23) Compensation for Research-Related Injury 
If a subject is injured, UC Davis Medical Center will always provide 
medical care. The sponsor (the Regents of the University of California) will 
pay for injuries / complications directly attributable to the study material. 
Insurance will pay for medically necessarily services for injuries / 
complications attributable to the disease or procedure. 
24) Economic Burden to Subjects 
Parts of this study are considered standard care to be covered by subjects or their 
insurance.  Standard care procedures include the pre-surgery fluoroscopy 
swallowing examination, endoscopy examination, and pregnancy test.  After the 
surgery, standard care includes follow-up clinic visits. 
 
25) Consent Process 
The informed consent process will occur at 2521 Stockton Blvd, 
Sacramento, CA 95817, in the Voice and Swallowing Center of the 
Department of Otolaryngology as per SOP: Informed Consent Process for 
Research (HRP-090). The potential subject is free to take as much time as 
they would like between the time that they are informed about the study 
and consenting.  During the consent process, the potential subject will be 
asked at certain periods of time to reiterate what is described in the 
consent document to ensure that they understand the study. Patients will 
be asked to sign a HIPAA Authorization for Research form at the time of 
consent. 
Non-English speaking subjects will not be asked to participate.  
Due to the inclusion / exclusion criteria of this study, adults unable to 
consent will not be included in this study. 
26) Process to Document Consent in Writing 
We will follow the standard operating procedures for the written document 
of consent as all participating subjects will be asked to sign the informed 
consent. 
27) Drugs or Devices 
The SED is manufactured by Kluge Design, Inc. (Rogers, MN), an FDA GMP 
Compliant, ISO:13485:2003 and ISO:9001:2008, company.  Life Science 
Outsourcing, Inc., an FDA registered and ISO 13485:2003 certified full service 
Medical Device Contract Manufacturer located in Brea, California, will clean, 
package and sterilize the SEDs and ship them via FedEx to the UC Davis 
Swallowing Center outpatient clinic operating room (OR) in the Glassrock 
Building. The administrative nurse responsible for the OR will record the shipment 
on the study’s Inventory Sheet for SED Implant. The nurse will verify that the 
shipment arrived intact, the contents match the shipping invoice, and the packaged 
implants do not have any breach of packaging or damage. Implants are to be 
discarded if any breach or damage is found.  

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SED implants will be stored and locked in closed cabinets of the UC Davis 
Swallowing Center outpatient operating room where all sterilized surgical 
equipment is located. The temperature range in the OR is monitored to be 68-72°F, 
and the humidity range is monitored to be 20-60%. Hand hygiene facilities are 
adjacent to the storage area. The ventilation system is designed so that the air flows 
out of the sterile storage area. Packaging has been validated for 36 months per ISO 
11607-1:2006.  
 
Before surgery, the serial number of the SED that is checked-out for surgery, date, 
and device condition will be recorded on the Inventory Sheet for SED Implants. 
The serial number will also be written on the CRF and the bar code sticker from the 
sterilized packaging will be attached to the CRF. The SED package will be opened 
5 minutes before surgery. If there is any breach in packaging or damage to the 
device at this time, the SED will be discarded. Similarly, the SED will be discarded 
and replaced if it is dropped prior or during surgery, as explained in the Healthcare 
Providers Instructions For Use. Before surgery, staff will conduct standard UC 
Davis Health System patient identification procedure. 
Dr. Peter Belafsky has obtained an IDE (G100100-02) for the SED. On 
November 22, 2013, the FDA approved the IDE.  Dr. Belafsky will 
undertake the responsibilities of IDE sponsors and investigators as listed in 
21 CFR 812 and obtain IRB approval before beginning the study. 
The UC Davis Health System Electronic Medical Records was certified as 
compliant with 21 CFR Part 11 by Teresa Porter, Chief Compliance Officer, 
UC Davis Health System, on January 18, 2011. 
All investigators of this clinical trial will comply with the regulations 
governing financial disclosure by clinical investigators as described in 21 
CFR Part 54.  Investigators with no disclosable financial interests in or 
arrangements with the sponsor of the covered clinical study will submit 
Form FDA 3454.  Those who have disclosable financial interests in and/or 
arrangements with the sponsor will submit Form FDA 3455. 
In regards to Quality System Regulation (QS)/Good Manufacturing Practices 
(GMP) - 21 CFR Part 820, the SED medical device is manufactured by Kluge 
Design, Inc. (Rogers, MN), an FDA GMP Compliant, ISO:13485:2003 and 
ISO:9001:2008, company.  Life Science Outsourcing, Inc., an FDA registered and 
ISO 13485:2003 certified full service Medical Device Contract Manufacturer 
located in Brea, California, will clean, package and sterilize the SEDs and ship 
them via FedEx to the UC Davis Swallowing Center outpatient clinic operating 
room (OR) in the Glassrock Building. Validations of mechanical testing and 
cleaning, packaging, and sterilizing were included in the approved IDE amendment. 
The implants will be stored and locked in closed cabinets of the UC Davis 
Swallowing Center outpatient operating room where all sterilized surgical 
equipment is located. The temperature range in the OR is monitored to be 68-72°F, 
and the humidity range is monitored to be 20-60%. Hand hygiene facilities are 
adjacent to the storage area. The ventilation system is designed so that the air flows 

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out of the sterile storage area. Packaging has been validated for 36 months per ISO 
11607-1:2006. These conditions are in conformance to AAMI ST79. 

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