Solo+ TTD 的办公室临床研究 (VENTY)
Solo+ 鼓膜置管装置的关键在诊临床研究
The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.
研究概览
详细说明
The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to <13 years.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Alabama
-
Alexander City、Alabama、美国、35010
- Southern Head & Neck Surgery
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Huntsville、Alabama、美国、35801
- North Alabama ENT
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Opelika、Alabama、美国、36801
- East Alabama ENT
-
-
California
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Sacramento、California、美国、95661
- Sacramento ENT
-
-
Kentucky
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Louisville、Kentucky、美国、40220
- Advanced ENT & Allergy
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Pennsylvania
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Bethlehem、Pennsylvania、美国、18017
- Specialty Physician Associates
-
-
South Carolina
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Columbia、South Carolina、美国、29203
- South Carolina ENT
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients aged ≥6 months to <13 years
- Planned tympanostomy tube insertion
- Patient is able to commit to the follow-up visits and assessments
Exclusion Criteria:
- Anatomy that precludes sufficient visualization of the tympanic membrane
- Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
- Narrow ear canals
- Congenital or craniofacial abnormalities affecting the ear
- No baseline audiometry or tympanometry
- Familial history of insensitivity to anesthetic components
- Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Solo+ Tympanostomy Tube Device (Solo+ TTD)
The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure. |
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Procedure Success
大体时间：Intra-operative
|
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears |
Intra-operative
|
|
Rate of Adverse Events
大体时间：24 months
|
Incidence and nature of device- or procedure-related adverse events |
24 months
|
合作者和调查者
调查人员
- 学习椅：Matija Daniel、Queen's Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.