NCT02347943终止不适用
OASIS Global Sinus Surgery Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 252
- 主要终点
- Number of Participants Completing Follow-Up Visits
研究概览
简要总结
This study evaluates long-term safety and effectiveness of primary sinus surgery in a real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using commercially available sinus instrumentation (e.g. sinus balloon catheters, powered microdebriders, manual instruments).
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
- •Age ≥ 18 years or minimum adult age as required by local regulations
- •The subject has a planned primary sinus surgery, which includes either traditional transnasal endoscopic sinus surgery (ESS), balloon sinus dilation (BSD) or a hybrid procedure
- •Subjects diagnosed by ENT surgeon with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS) per AAO-HNS or EPOS adult sinusitis clinical practice guidelines
- •The subject has been informed of the nature of the registry and has consented to participate and authorized the collection and release of medical information by signing a consent form
- •Subject is able to read and understand local language
排除标准
- •Prior sinus surgery. Septoplasty, Nasal Polypectomy, Septorhinoplasty, Nasal Valve and Turbinate Reduction surgeries are not exclusions
- •Planned surgery of any of the following : orbital decompression, skull base, neoplasm, lacrimal, UPPP, aesthetic surgery, Potts Puffy tumor, Draf III
- •Planned external approaches (i.e. not trans-nasal)
- •Planned off-label usage of balloon sinus dilation products.
- •Balloon sinus dilation performed with a non-Acclarent balloon product
结局指标
主要结局
Number of Participants Completing Follow-Up Visits
时间窗: 2 years
次要结局
未报告次要终点
研究者
相似试验
招募中
不适用
Impact of Sinus Surgery on Individuals With Cystic FibrosisChronic Rhinosinusitis (Diagnosis)Cystic FibrosisNCT04469439University of California, Los Angeles170
已完成
不适用
Clinical and Radiographic Evidence of Alleviation of Preoperative Chronic Sinusitis After Open Sinus Allogeneic Bone Augmentation Surgery: A Retrospective Observational StudyChronic SinusitisOpen Sinus ElevationNCT06773494Misr International University36
撤回
不适用
Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus SurgerySinusitisNCT02900794Texas Tech University Health Sciences Center
已完成
3 期
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)Chronic SinusitisNCT00231062Integra LifeSciences Corporation115
终止
不适用
QOL Outcomes in CRS With PolypsChronic Rhinosinusitis, PolypsNCT03144375University of Miami28