The PIO III Study: In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- the change from baseline to day 90 in bilateral polyp grade
研究概览
简要总结
Report on the technical feasibility and outcomes of in-office placement of PROPEL or PROPEL mini implants immediately following ethmoid sinus surgery
详细描述
The PROPEL mometasone furoate-releasing implant (Intersect ENT, Menlo Park, CA) is the first FDA-approved device for reducing the need for post-operative interventions by maintaining patency and delivering steroid medication directly into the ethmoid cavity following surgery. Five recently published clinical trials have demonstrated that the mometasone furoate-releasing implant placed in the hospital operating room or in the office setting produces statistically significant reductions in inflammation, polyp formation, and postoperative adhesions. In addition, the implant has been found to significantly reduce the need for postoperative prescription of oral steroids and to decrease the frequency of postoperative lysis of adhesions. Minimal adverse effects were reported in these trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Confirmed diagnosis of CRS (Chronic Rhinosinusitis) based on the 2015 Clinical Practice Guideline for Adult Sinusitis [6]
- •Prior ESS (Ethmoid Sinus Surgery) including bilateral total ethmoidectomy at least 90 days prior to being considered for this study
- •Planned ESS includes bilateral polypectomy
- •ESS including bilateral polypectomy 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.
- •Bilateral polyposis (minimum grade 2 on each side) originating from the ethmoid sinus region
- •Complaints of at least 2 of the 5 hallmark symptoms of chronic sinusitis: nasal obstruction/congestion, post-nasal discharge, thick nasal discharge, facial pain/pressure, or decreased sense of smell.
- •Minimum symptom threshold (Nasal Obstruction/Congestion minimum score of 2 on scale from 0 to 3)
- •Failed medical therapy within the preceding 12 months
排除标准
- •Not able to give consent
- •Oral-steroid dependent condition
- •Allergy or intolerance to corticosteroids
- •Clinical evidence of bacterial sinusitis or invasive fungal sinusitis
- •Pregnancy
结局指标
主要结局
the change from baseline to day 90 in bilateral polyp grade
时间窗: baseline and 90 days from surgery
clinical investigator assessed and by an independent reviewer based on video-endoscopy review
the change from baseline to day 90 in nasal obstruction / congestion score
时间窗: baseline and 90 days from surgery
nasal obstruction/congestion scored by patients
次要结局
- Adhesion Scarring Score(Baseline, Day 14, Day 30, Day 90 and Month 6)
- Inflammation Score(Baseline, Day 14, Day 30, Day 90 and Month 6)
- Nasal Obstruction/ Congestion Score(Day 14, Day 30, Month 6)
- Medication Requirements(Month 6 post-surgery versus Month 6 post-baseline)
- Patient Preference Questionnaire(Baseline procedure, Day 90)
- Ethmoid Sinus Obstruction(Baseline, Day 14, Day 30, Day 90 and Month 6)
- Coagulum/ Crusting Score(Baseline, Day 14, Day 30, Day 90 and Month 6)
- Implant Placement Success Rate(time of surgery)
- Bilateral Polyp Grading(Day 14, Day 30, Month 6)
- Sino-Nasal Outcome Test (SNOT 22)(Baseline, Day 14, Day 30, Day 90 and Month 6)