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

Dysphagia Clinical Trial

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

Status Terminated

Clinical 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. 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Oropharyngeal Dysphagia (OPD)

• NCT number: NCT02296528
• Study type: Interventional
• Source: University of California, Davis
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Completion date: October 17, 2022