临床试验/NCT02278484

NCT02278484已完成不适用

XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study

Entellus Medical, Inc.8 个研究点分布在 1 个国家目标入组 50 人开始时间: 2014年9月最近更新: 2017年4月11日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Entellus Medical, Inc.
入组人数: 50
试验地点: 8
主要终点: Technical Success: Sinuses Successfully Treated With Balloon Dilation

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.

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 21 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.

排除标准

•History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)

结局指标

主要结局

Technical Success: Sinuses Successfully Treated With Balloon Dilation

时间窗: Index procedure

Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.

Complications

时间窗: Index procedure through 3-month follow-up

Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.

次要结局

Change in Quality of Life From Baseline Through Completion(Baseline to 6-month follow-up)
Number of Subjects Who Undergo a Revision or Additional Surgery During the Study(Procedure-6 month follow up)

研究者

发起方

Entellus Medical, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (8)

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