Product Surveillance Registry (PSR) Ear, Nose and Throat- PROPEL Drug-Eluting Sinus Stent Family EXTEND Cohort
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Medtronic
- 入组人数
- 100
- 主要终点
- To characterize the SNOT-22 total score change from baseline to Month 6 in patients with CRS undergoing FESS
研究概览
简要总结
The purpose of this study is to confirm long-term clinical safety and performance, acceptability of identified risks, and detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling in a real-world setting.
详细描述
Ongoing clinical investigation for the purpose(s) of:
- Providing continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use
- Obtaining real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used
- Supporting post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/or regulatory authority requests
- Obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions
- Providing clinical data to support health economics and clinical outcomes research
Enrollment is estimated to take place at up to 10 sites in Europe over 12 months. A single site may enroll no more than 30 patients. Patients may be enrolled up to 60 days prior to the baseline procedure. Subjects will be followed for a total duration of12 months postoperatively.
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
- •Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
- •Patient has or is intended to receive or be treated with an eligible Medtronic product
- •Patient is consented within the enrollment window of the therapy received, as applicable
排除标准
- •Patient who is, or is expected to be, inaccessible for follow-up
- •Participation is excluded by local law
- •Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
结局指标
主要结局
To characterize the SNOT-22 total score change from baseline to Month 6 in patients with CRS undergoing FESS
时间窗: From baseline (prior to FESS procedure and sinus implant) to 6 months post procedure
The primary objective is to characterize the Sino-Nasal Outcome Test 22 item (SNOT-22) total score change from baseline to Month 6. The SNOT-22 assesses 22 symptoms associated with Chronic Rhinosinusitis (CRS) with a value from 0 (no problem) to 5 (problem as bad as it can be). The total score is assessed by summing the score for each of the 22 items. Baseline SNOT-22 total scores are expected to be higher prior to Functional Endoscopic Sinus Surgery (FESS) and implant of the sinus implant(s) . A decrease in SNOT-22 score at 6 months would indicate improvement in the patient's CRS symptoms.
次要结局
未报告次要终点