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

April 15, 2026 updated by: Peter Belafsky, MD

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Department of Otolaryngology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Profound oropharyngeal feeding tube dependent dysphagia < 12 months duration.
  • Esophageal phase dysphagia as defined as personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, stricture, eosinophilic esophagitis, erosive peptic esophagitis, and/or systemic disease affecting the esophagus.
  • Able to safely consume any food or liquid by mouth, as documented by fluoroscopic swallow study.
  • Normal UES opening, as evidenced by UES opening greater than .55 cm for individuals under 65 years of age and greater than .40 cm for individuals over 65 years of age on fluoroscopic swallow study.
  • Currently pregnant, as evidenced by a positive result on a pregnancy test if the patient is within child bearing age (younger than 60 years of age).
  • 17 years of age and younger, acceptable forms of documentation for verification of age include birth certificate, passport, and/or license.
  • Success full receipt of dysphagia therapy or < 3 months of dysphagia therapy within 3 months of study enrollment.
  • Lack of manual dexterity to operate swallowing expansion device as determined by a Block and Box Test (BBT) score below the normal limits per age, sex, and hand.
  • Inability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds.
  • Lack of cognitive ability to operate swallowing expansion device or provide informed consent as evidenced by an Abbreviated Mental Test Score (AMTS) score less than 6.
  • Active tumor involving the cricoid or laryngeal cartilage.
  • Known allergic reaction to titanium as evidenced by personal history of allergic or adverse reaction to titanium.
  • Infection of cartilage, head, and/or neck at time of evaluation and/or implantation as documented by recent imaging study or abnormal physical examination.
  • Presence of a tracheotomy tube or airway obstruction necessitating a tracheotomy tube.
  • A documented history of noncompliance with recommendations to take nothing by mouth.
  • Patients with an insensate larynx. Laryngeal sensation will be assessed with laryngopharyngeal sensory testing. An insensate larynx is defined as a laryngopharyngeal sensory threshold < 6 mmHg air pulse pressure or a complete absence of the laryngeal adductor reflex on palpation of the arytenoid with a flexible laryngoscope.
  • Patients with a current, at the time of evaluation, and/or history of Zenker's diverticulum.
  • Patients with sialorrhea at the time of evaluation with or without oral commissure incompetence.
  • Patients with profound xerostomia at the time of evaluation.
  • Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation.
  • Patients with a current, at the time of evaluation, and/or history of immunosuppression, as defined by the patient having a diagnosed immunodeficiency disorder or on immunosuppressive medication.
  • Patients with a current, at the time of evaluation, and/or history of coagulopathy, as defined by the patient having a diagnosed coagulation disorder or on anticoagulation medication (e.g., baby aspirin, over-the-counter non-steroidal anti-inflammatories, herbal agents, and warfarin, etc.) that cannot be temporarily stopped for the procedure.
  • Patients taking sedatives, narcotics, muscle-relaxants, anxiolytics, medical marijuana, alcohol, nicotine, medicinal nicotine, or other mind-altering medications that may affect safe patient use of the swallowing device.
  • Patients taking antifibrotic medications.
  • Patients with bilateral vocal fold immobility in any position, as evidenced on endoscopy.
  • Patients with unilateral vocal fold immobility and unable to attain complete glottic closure, as evidenced on endoscopy.
  • Patients with current, at the time of evaluation, and/or documented history of subglottic stenosis, as evidenced on endoscopy.
  • Patients with current, at the time of evaluation, and/or documented history of airway obstruction, as evidenced on endoscopy.
  • Patients with a life expectancy < 2 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Swallowing Expansion Device
Titanium swallowing expansion device
Device: Swallowing Expansion Device
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.
Other Names:
  • SED

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Before implantation, 2 months and 2 years post implantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Functional Oral Intake Scale
Time Frame: Before implantation, 2 months and 2 years post implantation

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:

  1. No oral intake
  2. Tube dependence with minimal/inconsistent oral intake
  3. Tube supplements with consistent oral intake
  4. Total oral intake of a single consistency
  5. Total oral intake of multiple consistencies requiring special preparation
  6. Total oral intake with no special preparation, but must avoid specific foods or liquid items
  7. Total oral intake with no restrictions
Before implantation, 2 months and 2 years post implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peter Belafsky, MD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Belafsky, MD PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 619595

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