Phagenyx® Registry Study: Evaluating Swallowing Therapy Outcomes and Recovery in the U.S.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- Swallowing safety
研究概览
简要总结
A retrospective, open-label, matched-control registry study designed to characterize the effectiveness of Pharyngeal Electrical Stimulation (PES) to improve swallowing in patients with severe dysphagia post stroke when delivered using the Phagenyx® System in real-world clinical settings in hospitals in the United States of America (US).
详细描述
The study will consist of a Treatment Group and a Control Group. The Treatment Group will include patients who have undergone PES treatment for severe dysphagia. The Control Group will consist of patients that qualify for PES treatment but are not treated with PES in the time period prior to implementing PES. Patients will be treated per standard of care at each institution. Each Treatment patient will receive treatment with PES in addition to other standard of care dysphagia therapies. Control subjects will receive standard of care dysphagia therapies only (no PES or other electrical stimulation therapies for dysphagia are permitted). Performance of the Phagenyx® System will be analyzed by comparing treatment outcomes for patients in the PES Group compared to patients in the Control Group.
The study will include patients with severe dysphagia post stroke. The main clinical outcomes will be assessed using the participating sites' standard of care methodology and will evaluate improvements in swallowing and reduction in associated treatments and complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phagenyx® System Group Patients: Patients underwent treatment with the Phagenyx® System for a minimum of 3 treatments.
- •Control Group Patients: Patient requires a nasogastric feeding tube for severe dysphagia and required dysphagia treatment.
- •Willing and able to provide appropriate informed consent (if required).
排除标准
- •Primary endpoint outcome data not collected or not available.
- •In the investigator or sponsor's opinion the patient is not considered suitable.
- •Participation in another interventional study (medicinal or device) that could influence the outcomes of PES.
- •Treatment of dysphagia with other forms of electrical stimulation.
结局指标
主要结局
Swallowing safety
时间窗: Baseline to 2 (+1 days) post final PES treatment (Approximately 6 days).
Swallowing safety based on the change in Penetration Aspiration Scale (PAS) score from baseline (pre-PES treatment) to 2 (+1 days) post PES treatment.
Nutritional Management
时间窗: Baseline to Hospital Discharge (up to approximately 30 days)
Nutritional management improvement based on the change in Functional Oral Intake Score (FOIS) from baseline (pre-PES treatment) to hospital discharge
次要结局
未报告次要终点