The PROGRESS Study: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implants Following Surgical Opening of the Frontal Sinus for Chronic Sinusitis: A Randomized Blinded Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 20
- 主要终点
- Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
研究概览
简要总结
The objective of the PROGRESS Study is to assess the safety and efficacy of the Propel Mini and Propel Nova steroid-eluting Sinus Implants when placed in the frontal sinus opening following frontal sinus surgery in patients with chronic sinusitis.
详细描述
This is a prospective, randomized, blinded, controlled, multicenter study enrolling two consecutive cohorts of up to 80 patients each (Propel Mini cohort followed by Propel Nova cohort). The study patients will undergo implant placement on one side following ESS that includes bilateral frontal sinus surgery by traditional surgical technique or balloon dilation.
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
- Double (Participant, 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 CRS confirmed by CT scan and defined as symptoms lasting longer than 12 consecutive weeks in duration with inflammation of the mucosa of the nose and paranasal sinuses.
- •Patient has a clinical indication for and has consented to ESS including bilateral frontal sinus surgery.
- •Chronic sinusitis diagnosis confirmed and documented by CT scan within 6 months of the procedure.
- •Patient has bilateral disease in both frontal sinuses confirmed by Lund-Mackay score of ≥1 on each side.
- •Planned sinus surgery includes bilateral ethmoidectomy (if judged necessary) and frontal sinus enlargement using Draf II (A or B) dissection or balloon dilation, with minimum of 5-mm diameter opening created.
- •Technique used for frontal sinus surgery is the same on both sides (e.g. surgical dissection alone bilaterally, balloon dilation alone bilaterally, or both bilaterally)
- •Septoplasty for access to the ostio-meatal complex is permitted.
- •ESS including bilateral frontal sinus surgery has been successfully completed without significant complication that, in the opinion of the investigator, would confound study results, and the patient's anatomy remains amenable to implant placement.
排除标准
- •Known history of immune deficiency such as immunoglobin G or A subclass deficiency, or Human Immunodeficiency Virus (HIV)
- •Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or asthma or other condition
- •Known history of allergy or intolerance to corticosteroids or mometasone furoate
- •Clinical evidence of acute bacterial sinusitis
- •Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
- •Active viral illness
- •Concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease
- •Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90 day follow-up period
- •Currently participating in another clinical trial
- •History of insulin dependent diabetes mellitus
- •Patient has previously undergone ESS and experienced a CSF leak or has compromised vision as a result of a complication in a prior ESS procedure
- •Significant complication during the current frontal sinus surgery procedure such as excessive blood loss, CSF leak or punctured lamina papyracea
- •Current ESS including frontal sinus surgery is aborted for any reason.
- •At least one side is not amenable for implant placement.
结局指标
主要结局
Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
时间窗: Day 30
The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)
时间窗: Day 30
The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews. Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response).
次要结局
- Inflammation (Propel Mini Cohort)(Day 30)
- Occlusion/Restenosis (Propel Mini Cohort)(Day 30)
- Need for Post-operative Interventions (Propel Mini Cohort)(Day 30)
- Need for Surgical Interventions (Propel Mini Cohort)(Day 30)
- Need for Post-operative Interventions (Propel Nova Cohort)(Day 30)
- Need for Surgical Interventions (Propel Nova Cohort)(Day 30)
- Inflammation (Propel Nova Cohort)(Day 30)
- Occlusion/Restenosis (Propel Nova Cohort)(Day 30)