TerminatedNot Applicable

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

Stopped: PI decided to close study

United States4 participantsStarted 2014-06

Plain-language 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. 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 closur…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Upper Esophageal Sphincter (UES) Opening

Timeframe: Before implantation, 2 months and 2 years post implantation

Trial details

NCT IDNCT02296528

SponsorPeter Belafsky, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-17

Results submitted2023-12-17

View on ClinicalTrials.gov More Oropharyngeal Dysphagia (OPD) trials