Safety and Efficacy of Cryoablation in Management of Sialorrhea in Patients With Neurological Disorders.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
研究概览
简要总结
To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
Secondary Objective: To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
Duration:
Estimation for Recruitment: 12 months Estimation for Procedure/Trial: 1 visit with an overnight observation Estimation for Subject Follow Up: 7 days, 14 days, 28 days, 90 days, and 180 days, post ablation, with ultrasound of the bilateral submandibular glands at 28 days and 180 days post ablation Total Expected Duration for Clinical Trial: 2 years
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent and assent (as appropriate) obtained from the subject/caregiver who opted voluntarily to participate in the procedure
- •Male or female 2 to 65 years of age
- •Confirmed diagnosis of sialorrhea as documented in their medical record
- •Clinically stable with no significant changes in health status in the 2 weeks before the ablation
- •Patients diagnosed with cerebral palsy, or other neurological impairment documented in their medical record
排除标准
- •Open sores/ulcers on skin overlying the submandibular glands
- •Contraindications to surgery/general anesthesia e.g; coagulopathies, life threatening arrhythmias
- •Upper respiratory airway obstruction, e.g: severe dystonia
- •History of previous local surgery
- •Any congenital abnormalities that may preclude cryoablation, such as vascular abnormalities or atypical size/location
- •Patients that have received salivary gland Botulinum toxin injections within the prior 3 months
- •Subjects unlikely to complete the study as determined by the principle investigator
结局指标
主要结局
To evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.
时间窗: 2 years
1. Safety Parameters: Major adverse events will be submitted to the Agency and be reviewed by the medical monitor. In case unexpected events should occur we will evaluate and report them. 2 Methods for Analyzing Safety Parameters: Prior to the enrollment of the first research subject, the study sponsor will organize and conduct an initial meeting for the medical monitor. The medical monitor will review AE logs, deviation logs, procedural details, call logs, phone scripts, study progress notes, patient medical charts, and completed questionnaires, every 5 patients, or quarterly, whichever takes place first. The sponsor-investigator will oversee the conduct of the medical monitor. Directives provided by the medical monitor will be reported accordingly and as necessary to the Food and Drug Administration and the IRB.
次要结局
- To evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations.(2 years)
研究者
Dean Nakamoto
Division Chief, Abdominal Imaging - UH Cleveland Medical Center
University Hospitals Cleveland Medical Center