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 : September 6, 2022
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|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 2023|
|Estimated Study Completion Date :||April 2023|
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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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|
|Responsible Party:||Peter Belafsky, MD, Professor, University of California, Davis|
|Other Study ID Numbers:||
|First Posted:||November 20, 2014 Key Record Dates|
|Last Update Posted:||September 6, 2022|
|Last Verified:||September 2022|
Feeding Tube Dependent
Digestive System Diseases