Neurogenic Dysphonia/Dysphagia Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 146
- 试验地点
- 5
- 主要终点
- Collect and characterize the different types (and frequency) of initial assessments/evaluations performed on patients.
研究概览
简要总结
The Neurogenic Dysphonia/Dysphagia Registry is designed to be purely observational (i.e. non-interventional, exploratory). Patient data collected from the registry is expected to be consistent with any information which can be obtained during usual care of patients with dysphonia/dysphagia treated with vocal fold augmentation.
详细描述
The Neurogenic Dysphonia/Dysphagia Registry is a 510K post-clearance multicenter, observational, open-label registry of the benefits and risks of management and outcomes of patients with neurogenic dysphonia/dysphagia who have received vocal fold augmentation (VFA).
Enrollment is open to all eligible patients meeting all of the inclusion and none of the exclusion criteria, with a target of 400 patients. Up to 100 sites in the US and abroad will be a part of the registry. Sites will provide retrospective data for active patients who have undergone VFA within the past 24 months at the site and also begin to prospectively enroll patients who are receiving VFA as a part of their usual care. Patients will be followed for up to five years prospectively, until lost to follow-up, or death.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females, ≥18 years of age
- •Diagnosis of neurogenic dysphonia/dysphagia
- •Under active treatment with VFA and follow-up care
排除标准
- •Patients with:
- •Vocal fold scar
- •Laryngeal cancer defect
- •Irradiation to the larynx
- •Laryngeal trauma
- •End-stage cancer
结局指标
主要结局
Collect and characterize the different types (and frequency) of initial assessments/evaluations performed on patients.
时间窗: 1 day
Characterize the initial assessment (e.g. types of assessments/evaluations performed and severity of voice, swallowing, cough as determined by patient reported outcomes where available)
Collect and characterize the different types (and frequency) of subsequent management of neurogenic dysphonia/dysphagia patients who receive VFA in terms of product used, evaluations performed and referrals and recommendations for further treatment
时间窗: 5 years
Characterize subsequent management of neurogenic dysphonia/dysphagia patients who receive VFA in terms of product used, evaluations performed and referrals and recommendations for further treatment
次要结局
- Collect types and frequency of different patient characteristics and medical care practices associated with improved health outcomes after VFA(5 years)
- Collect characteristics, management, and outcomes of patients who receive CaHA implants and thryoplasty(5 years)
- Collect patient reported outcomes (PRO) and clinician assessments to characterize voice, swallowing, and cough outcomes post-injection(5 years)
- Collect and measure information on the duration of effect of Prolaryn products and the need for re-injection(5 years)