ACTRN12619000169145招募中未知
Safety and Efficacy of the Swallow Expansion Device (SED) for Improvementof Swallowing in Patients with Aspiration Secondary to OropharyngealDysphagia: A Single-Site, Open-Label, Phase I Human Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1)Profound oropharyngeal dysphagia (with or without feeding tube) of greater than 12 months duration, as documented by the prevalence of aspiration on fluoroscopic swallow study.
- •2)Age > 18 years, acceptable forms of documentation for verification of age include birth certificate, passport, and/or driver’s license.
- •3)Diminished UES opening defined as less than .55 cm for individuals less than 65 years of age and less than .40 cm for individuals over 65 years of age on fluoroscopic swallow study.
- •4)Failure of > 3 months of dysphagia therapy within 3 months of study enrollment.
- •5)No documented history of noncompliance with feeding recommendations.
- •6)Cognition that is within normal limits, as evidenced by a Mini Mental State Exam score greater than 25.
- •7)Manual dexterity that allows manipulation of the device.
- •8)Physical strength to pull the SED forward, as evidenced by the ability to lift a 2kg weight off of a table and keep it elevated for 10 seconds.
- •9)Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations.
- •10)Bilateral vocal fold mobility or unilateral vocal fold immobility in which the individual is able to attain complete glottic closure as evidenced on endoscopy.
排除标准
- •1)Profound oropharyngeal dysphagia < 12 months duration.
- •2)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.
- •3)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.
- •4)Currently pregnant, as evidenced by a positive result on a pregnancy test if the patient is within child bearing age (younger than 45 years of age).
- •5)Age < 18 years
- •6)Not having received dysphagia therapy
- •7)Lack of manual dexterity to operate swallowing expansion device.
- •8)Inability to lift a 2kg weight off of a table and keep it elevated for 10 seconds.
- •9)Lack of cognitive ability to operate swallowing expansion device or provide informed consent.
- •10)Active tumor involving the cricoid or laryngeal cartilage.
- •11)Known allergic reaction to titanium as evidenced by personal history of allergic or adverse reaction to titanium.
- •12)Infection of cartilage, head, and/or neck at time of evaluation and/or implantation as documented by recent imaging study or abnormal physical examination.
- •13)Presence of a tracheotomy tube or airway obstruction necessitating a tracheotomy tube.
- •14)A documented history of noncompliance with recommendations or inability to attend follow up reviews. 15)Patients with an insensate larynx. Laryngeal sensation will be assessed with laryngopharyngeal sensory testing by laryngeal adductor reflex response on endoscopy.
- •16)Patients with a current, at the time of evaluation, and/or history of Zenker’s diverticulum.
- •17)Patients with sialorrhea at the time of evaluation with or without oral commissure incompetence.
- •18)Patients with profound xerostomia at the time of evaluation.
- •19)Patients with orocutaneous or pharyngocutaneous fistulae at the time of evaluation.
- •20)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.
- •21)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, OTC non steroidal antinflammatories, herbal agents, Warfarin, clopidogrel) that cannot be temporarily stopped for the procedure.
- •22)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.
- •23)Patients with bilateral vocal fold immobility in any position, as evidenced on endoscopy.
- •24)Patients with unilateral vocal fold immobility and unable to attain complete glottic closure, as evidenced on endoscopy.
- •25)Patients with current, at the time of evaluation, and/or documented history of subglottic stenosis, as evidenced on endoscopy.
- •26)Patients with current, at the time of evaluation, and/or documented history of airway obstruction, as evidenced on endoscopy.
- •27)Patients with a life expectancy < 2 years.
研究者
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