Safety and Efficacy of the Swallow Expansion Device (SED) for Improvement of Swallowing in Patients
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|ClinicalTrials.gov Identifier: NCT02296528|
Recruitment Status : Recruiting
First Posted : November 20, 2014
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Dysphagia (OPD) Dysphagia||Device: Swallowing Expansion Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
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 Name: SED
- 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.
- Change in Penetration Aspiration Scale (PAS) [ Time Frame: Before implantation, 2 months and 2 years post implantation ]Swallowing safety will be assessed with the Penetration Aspiration Scale (PAS) via videofluoroscopy. A scale of 1 indicates a safe swallow (material does not enter the airway). A score of 2-3 indicates mild, 4-5 moderate, and >5-8 indicates severe swallowing disability (material enters the airway, it passes below the vocal folds, and no effort is made to expel it). The patient is initially fed a 1 cc bolus of thin barium. If no aspiration is detected, the patient is then administered a 3 cc and then 20 cc bolus, or largest bolus possible, of barium. If any aspiration is detected at any stage of the study, the procedure is terminated immediately. The PAS will be calculated for the largest swallowed bolus size on fluoroscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296528
|Contact: Peter Belafsky, MD, Ph.Demail@example.com|
|Contact: Maggie Kuhn, MSfirstname.lastname@example.org|
|United States, California|
|University of California Department of Otolaryngology||Recruiting|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Peter Belafsky, MD PhD||University of California, Davis|