NCT07290140招募中不适用
A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Safety and Efficacy of Paclitaxel-Coated Sinus Balloon as an Adjunct to Endoscopic Sinus Surgery in Adult Chronic Rhinosinusitis Subjects
Airiver Medical, Inc.11 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年6月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 11
- 主要终点
- Primary safety
研究概览
简要总结
This is a prospective, multicenter, randomized, controlled, double-blind clinical trial enrolling 300 adult subjects with chronic rhinosinusitis (CRS) with and without nasal polyps (CRSwNP and CRSsNP) indicated for endoscopic sinus surgery (ESS).
详细描述
Subjects will be randomized in a 1:1 ratio for ESS with no additional treatment (control group) or ESS followed by Airiver ESSpand DCB sinus dilation of affected sinuses (treatment group) at up to 40 US based sites.
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
- •Male or female, aged ≥18 years
- •Confirmed diagnosis of CRS per the 2021 "International Consensus Statement on Allergy and Rhinology: Rhinosinusitis" definition.
- •Radiographic evidence of bilateral ethmoid disease on CT taken 6 months or less prior to study index procedure and at least 6 months after any prior ESS or nasal surgery, polypectomy, balloon sinus dilation, etc. as applicable
- •Radiographic evidence of bilateral frontal sinus and/or frontal sinus outflow tract disease
- •Baseline SNOT-22 score ≥ 30
- •Has failed previous medical treatment and is an appropriate candidate for primary or revision ESS of bilateral ethmoid sinuses and bilateral frontal/frontal sinus outflow tract
- •Willing and able to provide written informed consent
- •Willing and able to comply with all protocol follow up visits and assessments
排除标准
- •Nasal cavity tumor (malignant or benign)
- •Antrochoanal polyps
- •Previous complete middle turbinate resection
- •Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
- •History of prior lamina dehiscence or cerebrospinal fluid (CSF) leak in skull-based dehiscence
- •Concurrent condition requiring active chemotherapy and/or immunotherapy management
- •Subjects whose symptoms are too severe to undergo ESS (e.g., temperature >102.5F or extra-sinus manifestations, such as orbital cellulitis; dental or facial or brain abscess; cavernous vein thrombosis; or altered mental status
- •History of complications from prior ESS or balloon dilation procedure (e.g., CSF leak or injury to the skull base or orbital injury)
- •History of primary ciliary dyskinesia
- •Oral-steroid dependent conditions such as chronic obstructive pulmonary disease (COPD) or other conditions
- •Have evidence of significant baseline mucosal injury, ulceration, or erosion (e.g., exposed cartilage, perforation) on nasal examination
- •Acute purulent nasal infection or upper respiratory tract infection, including but not limited to acute bacterial rhinosinusitis (ABRS), acute rhinosinusitis (ARS), or COVID -19 within 2 weeks before the baseline visit.
- •Allergy or hypersensitivity to paclitaxel or structurally related compounds.
- •Subject has taken biologic drugs in the 6 months leading up to the screening visit or who expect to take biologics in the next 24 months.
- •Subject has taken oral corticosteroids in the 30 days leading up to their baseline appointment.
- •Subject who plans to undergo posterior nasal nerve ablation in the next 24 months.
- •Subject has a history of inability to tolerate nasal endoscopy
- •Concurrent medical condition that would affect the investigator's ability to evaluate the subject's condition or that could compromise subject safety, such as severe COPD, severe asthma
- •Pregnant or planning to become pregnant during the first 12 months of enrollment in the study
- •Subject who has undergone a nasal/sinus surgery including but not limited to ESS, polypectomy, septoplasty, turbinoplasty, balloon sinus dilation, placement of steroid releasing implants, posterior nasal nerve ablation in the 6 months prior to the baseline appointment.
- •Previous Draf III frontal sinus surgery or a study index procedure ESS is expected to be or is a Draf III sinus surgery.
- •Subject whose index procedure did not include bilateral ethmoid ESS and bilateral frontal ESS
- •Subject whose expected study index procedure includes steroid releasing implants or non-resorbable nasal packing/stents.
- •Subject whose study index procedure is aborted for any reason
- •Life expectancy <2 years
研究组 & 干预措施
• Treatment with the Airiver ESSpand DCB and ESS
Experimental
Subjects will have ESSpand DCB dilation of the ESS treated sinuses
Treatment with ESS
Active Comparator
Subjects will have ESS treatment at target sinuses
干预措施: ESS (Procedure)
结局指标
主要结局
Primary safety
时间窗: 30 days post- index procedure
Incidence of major adverse events (MAE) through 30 days post-index treatment.
Primary efficacy endpoint
时间窗: 6 months post-index procedure
Reduction in need for postoperative intervention in the ethmoid and /or frontal sinus within 6 months post-index procedure.
次要结局
- Hypothesis tested clinical responder rate at 12 months(12 months)
- Hypothesis tested mean adhesion/scaring grade of sphenoid sinus at 6 months, as assessed by the independent, blinded reviewer(6 months)
研究者
研究点 (11)
Loading locations...
相似试验
尚未招募
2 期
CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate CancerMetastatic Prostate CancerNCT07268794Fudan University112
招募中
2 期
Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic StrokeNCT07279493Kunming Pharmaceuticals, Inc.300
尚未招募
2 期
Nimotuzumab Combined With Nab-paclitaxel/Gemcitabine in the Perioperative Treatment of High-risk Resectable/Borderline Resectable Pancreatic CancerNCT07277452The First Affiliated Hospital with Nanjing Medical University156
招募中
不适用
Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast CancerNCT07285382wanghaibo120
尚未招募
不适用
The Percutaneous Interventional Surgery Control System for Pulmonary Nodule BiopsyNCT07277088Jiayuan Sun158