The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 14
- 主要终点
- Difference in FSO Patency by Blinded Reviewer
研究概览
简要总结
The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)
详细描述
A post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 study centers.
After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure™ Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the 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 (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
- 是
入选标准
- •Patient is 18 years of age or older.
- •Patient is willing and able to comply with protocol requirements.
- •Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and Rhinology, Rhinosinusitis 2021 (ICAR:RS) guidelines.
- •Bilateral disease in the frontal sinuses (Lund-Mackay CT score of ≥1 on each side) on CT scan within 90 days prior to the baseline.
- •A successfully completed in-office bilateral balloon dilation of the FSO with no complication on either side that, in the opinion of the clinical investigator is amenable for PROPEL Contour Sinus Implant placement in both FSO
排除标准
- •Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs prior to implant placement.
- •Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade > 2) unless reduced 30 days prior to the baseline procedure
- •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.
- •Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers.
- •Patients with electronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators (e.g. deep brain stimulation), programmable cerebrospinal fluid (CSF) shunts.
- •Patients with monopolar pacemakers (older designs, with lower resistance to interference) or ICD's (implantable cardioverter defibrillator).
- •Patients with implantable, body worn devices such as insulin pumps.
- •Evidence of purulence coming from paranasal sinuses or ostiomeatal complex.
- •Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue).
- •Active viral illness (e.g., flu, shingles).
- •Use of parenteral or injected steroids (e.g. Kenalog) 30 days prior to the baseline procedure.
- •Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure.
研究组 & 干预措施
PROPEL Contour Sinus Implant
Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.
干预措施: PROPEL Contour Sinus Implant (Device)
Balloon Sinus Dilation Alone
Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.
干预措施: Balloon Sinus Dilation Alone (Procedure)
结局指标
主要结局
Difference in FSO Patency by Blinded Reviewer
时间窗: Day 45
Side-to-side difference in frontal sinus ostium (FSO) patency at Day 45 based on cross-sectional area of FSO by computed tomography (CT) measurements performed by an independent, blinded reviewer. Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.
次要结局
- Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators(Days 21, 45, 90 and 180)
- FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer(Baseline, Day 45, and Day 180)
- CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer(Days 45 and 180)
- CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer(Days 45 and 180)
- Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators(Days 21, 45, 90 and 180)
- CT FSO Minimum Diameter by Blinded Reviewer(Days 45 and 180)
- Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators(Days 21, 45, 90 and 180)
- Inflammation Score in the Frontal Recess/FSO by Clinical Investigators(Days 21, 45, 90 and 180)
- Polyp Grade in the Ethmoid Sinus by Clinical Investigators(Days 21, 45, 90 and 180)
- RSI Score by Subject(Day 180)
- Implant Delivery Success by Clinical Investigators(Baseline)
- CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer(Days 45 and 180)
- CT Cross-sectional Area of FSO by Blinded Reviewer(Day 180)
- CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators(Days 45 and 180)
- Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators(Day 21, 45, 90, and 180)
- CRS Side-specific Symptom Score by Subject(Days 21, 45, 90 and 180)
- SNOT-22 Score by Subject(Day 180)