A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 20
- 主要终点
- Percentage of Sinuses Requiring Post-operative Intervention
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).
详细描述
The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS). The Propel implant is designed to provide a mechanical spacing function within the sinus anatomy to separate mucosal tissues, provide stabilization of the middle turbinate, and thereby prevent tissue adhesions from forming. The implant is coated with a small amount of mometasone furoate (a corticosteroid) in order to help minimize post surgical inflammation within the supported tissues.
The study utilizes an intra-patient control design to assess the safety and efficacy of the drug-coated implant compared to the non-drug coated implant that is identical in appearance.
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 has bilateral chronic sinusitis confirmed by CT scan and defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive weeks' duration.
- •Patient is indicated for and has consented to FESS.
- •FESS successfully completed without significant complication that in the opinion of the physician would confound study results and the patient's anatomy remains amenable to Sinus Stent placement.
- •CT Imaging Inclusion Criteria:
- •CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.
- •Patient has minimum total CT score (Lund-Mackay method) of
- •Patient has bilateral ethmoid sinus disease confirmed by CT.
排除标准
- •insulin dependent diabetics
- •oral steroid dependent condition
- •glaucoma, ocular hypertension, posterior subcapsular cataracts
- •middle turbinate resection
结局指标
主要结局
Percentage of Sinuses Requiring Post-operative Intervention
时间窗: 30-days
Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.
Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure
时间窗: 90 days
clinically significant IOP elevation is a change from baseline of \>10 mm Hg on sinus side with drug-coated implant but not on side with control implant
次要结局
- Percentage of Sinuses That Developed Frank Polyposis(30 days)