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

NCT02296528 | Terminated Results

• 1 other identifier: 619595
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dysphagia; Oropharyngeal Dysphagia (OPD)

Keywords

Feeding Tube Dependent

Outcome Measures

Primary Outcomes (1)

• 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.

  Before implantation, 2 months and 2 years post implantation

Secondary Outcomes (1)

• Change in Functional Oral Intake Scale

  Before implantation, 2 months and 2 years post implantation

Study Arms (1)

Swallowing Expansion Device

OTHER

Titanium swallowing expansion device

Device: Swallowing Expansion Device

Interventions

Swallowing Expansion Device 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.

Also known as: SED

Swallowing Expansion Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Peter Belafsky, MD: lead

Study Sites (1)

University of California Department of Otolaryngology

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Peter Belafsky
• Organization: UC Davis

pcbelafsky@ucdavis.edu

858.205.3366

Study Officials

• Peter Belafsky, MD PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 20, 2014
• Study Start: June 1, 2014
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: April 20, 2026
• Results First Posted: April 20, 2026

Record last verified: 2023-12

Locations

US (1)