A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation
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
- 17
- 主要终点
- Patency Rate
研究概览
简要总结
A randomized controlled trial
详细描述
This is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the United States. Study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.
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
- Single (Participant)
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
- •Patient has provided written informed consent using a form approved by the reviewing IRB.
- •Patient is 18 years of age or older.
- •Patient is willing and able to comply with protocol requirements.
- •Patient has CRS defined as sinonasal inflammation persisting for more than 12 weeks and complains of at least 2 of the 4 following symptoms: nasal blockage/obstruction/congestion, nasal blockage/obstruction/congestion, nasal discharge (anterior/posterior), facial pain/pressure, reduction/loss of smell
- •CRS diagnosis confirmed by CT scan within 3 months prior to enrollment
- •Bilateral frontal sinusitis confirmed by Lund-Mackay score of ≥1 on each side
- •Post-endoscopic sinus surgery, patient has bilateral obstruction of the frontal sinus ostia by scarring and/or polypoid edema.
- •Patient is a candidate for an in-office balloon dilation procedure.
- •In the opinion of the investigator, treatment with the Propel Mini Sinus Implant as an adjunct to balloon sinus dilation is technically feasible and clinically indicated in the frontal sinus ostia.
排除标准
- •Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus of grade 3 or 4 unless reduced prior to randomization in the study.
- •Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
- •Known history of allergy or intolerance to corticosteroids or mometasone furoate.
- •Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis.
- •Active viral illness (e.g., flu, shingles).
- •Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments through Day 180 post-procedure.
- •Currently participating in another clinical trial.
研究组 & 干预措施
PROPEL Mini Sinus Implant
Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation
干预措施: PROPEL Mini Sinus Implant (Device)
PROPEL Mini Sinus Implant
Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation
干预措施: Balloon Sinus Dilation Alone (Procedure)
Balloon Sinus Dilation Alone
In-office balloon dilation of the contralateral frontal sinus ostia (FSO) without implant placement
干预措施: Balloon Sinus Dilation Alone (Procedure)
结局指标
主要结局
Patency Rate
时间窗: Day 30
Patency of the frontal recess/frontal sinus ostia (FSO) was evaluated on a 3-point grading scale from 0 to 2, with 0=Patent, 1=Restenosed/partially occluded, and 2=Occluded. The percentage of sinuses with patency grade 0 and 1 was used to calculate the patency rate.
次要结局
- Inflammation Score(Day 30)