A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Rhinosinusitis (CRS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Reduction in Ethmoid Sinus Inflammation
研究概览
简要总结
The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.
详细描述
This was a prospective, multi-center, double blind trial that enrolled patients in three groups as described below. Two groups (Pilot 15 mm and Efficacy 25 mm) used a randomized, double-blind, intra-patient control study design to assess performance of the drug-coated Splint (received in one ethmoid sinus) compared to the control Splint (received in the contralateral ethmoid). The other group of patients (Safety/PK 25 mm) received bilateral drug-coated Splints, and served as a pharmacokinetics (PK) study group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 is 18 years of age or older.
- •Patient has a diagnosis of bilateral CRS defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration.
- •Patient has a clinical indication for and has consented to bilateral FESS.
- •CRS diagnosis documented by CT scan within 60 days of the procedure.
- •Patient has minimal total CT stage (Lund-Mackay method) of
- •Patient has bilateral disease defined as minimal CT stage per side of ≥3.
排除标准
- •Oral-Steroid dependent COPD, asthma or other condition.
- •Immune deficiency (IGG subclass deficiency or IGA deficiency).
- •Symptomatic coronary artery disease.
- •Patient undergoing chemotherapy treatment.
- •Morbid obesity (BMI > 40) or a BMI that, in the opinion of the physician, would compromise health and participation in the study.
- •Evidence of active infection.
结局指标
主要结局
Reduction in Ethmoid Sinus Inflammation
时间窗: 21 days
Inflammation was scored by the physician using a 100-mm Visual Analog Scale (VAS) during endoscopic evaluation with range of 0 to 100mm. The term inflammation was used as a global descriptor defined to include mucosal edema, erythema, hypertrophy and polypoid changes. 0 represented no inflammation and 100mm was defined as "Severe, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes".
Device Success Rate
时间窗: Baseline
Device success rate defined as a ratio where the numerator is the number of successful deployments of the Sinexus Intranasal Splint and the denominator is the number of attempted sinuses. Deployment was considered successful if the implant procedure concluded with a successful splint placement on the intended side.
次要结局
- Middle Meatus Patency(30 days)
- Significant Adhesion Occurrence(30 days)
- Middle Turbinate Lateralization(30 days)
- Polypoid Tissue Changes(30 days)