Oropharyngeal Dysphagia (OPD)NCT02296528
Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients
A study testing Swallowing Expansion Device in people with Oropharyngeal Dysphagia (OPD) and Dysphagia, run by Peter Belafsky, MD at 1 site in United States.
Trial summary
Biomedical devices, such as artificial joints and pacemakers, are accepted and commonly used in medicine. While great progress in biomedical devices has been made for many other disorders, there is currently no device available to assist with the act of deglutition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia (OPD), Dysphagia
- What is being tested?
- Swallowing Expansion Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 17 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Department of Otolaryngology
Sacramento, California, 95817
About this study
Official 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 1 Human Trial
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. The investigators 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).
Read the detailed description
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.
- Conditions
- Oropharyngeal Dysphagia (OPD), Dysphagia
- Being tested
- Swallowing Expansion Device
- Keywords
- Feeding Tube Dependent
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing Expansion DeviceDevice
Also called SED
SED looks like the letter "T" and 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" with a small ring. The post permanently sticks out from the throat, like a skin piercing. 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.
| Study group | Role | What they receive |
|---|---|---|
| Swallowing Expansion Device | Other | Titanium swallowing expansion device Receives: Device: Swallowing Expansion Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Esophageal Sphincter (UES) Opening
UES opening will be measured via fluoroscopy. 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 measured. If swallowing is 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 swallowing.
Measured: Before implantation, 2 months and 2 years post implantation
Secondary outcomes (1)
Change in Functional Oral Intake Scale
A validated semi-quantitative scale to report functional oral intake.
FOIS scale range (1-7) and indicating 1= no oral intake and 7= oral intake with no restrictions. Below is the detailed scale:
- No oral intake
- Tube dependence with minimal/inconsistent oral intake
- Tube supplements with consistent oral intake
- Total oral intake of a single consistency
- Total oral intake of multiple consistencies requiring special preparation
- Total oral intake with no special preparation, but must avoid specific foods or liquid items
- Total oral intake with no restrictions
Measured: Before implantation, 2 months and 2 years post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJun 2014
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Why it stopped: PI decided to close study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oropharyngeal Dysphagia (OPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Belafsky, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Belafsky, MD, University of California, Davis
- Investigators
- Peter Belafsky, MD PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296528
- Sponsor's protocol ID
- 619595
- Status last verified
- Dec 2023
- First submitted
- 5 Nov 2014
- Last updated
- 20 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 1 Human Trial
- ClinicalTrials.gov ID
- NCT02296528
- Acronym / sponsor ID
- 619595
- Conditions
- Oropharyngeal Dysphagia (OPD), Dysphagia
- Keywords
- Feeding Tube Dependent
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decided to close study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Peter Belafsky, MDUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 20 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The investigators 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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swallowing Expansion Device | Other | Device: Swallowing Expansion DeviceTitanium swallowing expansion device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (29 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swallowing Expansion DeviceAlso: SEDSED looks like the letter "T" and 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" with a small ring. The post permanently sticks out from the throat, like a skin piercing. 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. | Device | Swallowing Expansion Device |
Primary outcome
Change in Upper Esophageal Sphincter (UES) Opening
Time frame: Before implantation, 2 months and 2 years post implantation
UES opening will be measured via fluoroscopy. 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 measured. If swallowing is 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 swallowing.
1 secondary outcome
Change in Functional Oral Intake Scale
Time frame: Before implantation, 2 months and 2 years post implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Belafsky, MD PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swallowing Expansion Device in people with Oropharyngeal Dysphagia (OPD) and Dysphagia, run by Peter Belafsky, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Upper Esophageal Sphincter (UES) Opening (time frame: Before implantation, 2 months and 2 years post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.