NCT07286201Enrolling By Invitation不适用
A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of a Bioresorbable Nasal Dressing Containing Mometasone Furoate Compared to a Steroid-eluting Sinus Stent
Polyganics BV9 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年3月19日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 110
- 试验地点
- 9
- 主要终点
- Rate of Serious Adverse Events
研究概览
简要总结
The primary objective of the study is to evaluate the safety and effectiveness of OCEAN as an adjunct aid in wound healing after nasal/sinus surgery and to demonstrate that OCEAN is non-inferior compared to a steroid-eluting sinus stent.
详细描述
A multicenter, randomized, single-blinded, controlled, intra-patient non-inferiority study enrolling 110 subjects at up to 13 sites in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Subject is 18 years or older
- •Subject is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitus with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP) and is indicated for bilateral complete ethmoidectomy (anterior and posterior ethmoidectomy) at a minimum. Additional sinuses may be operated on at the surgeon's discretion.
- •Subject is willing and able to provide informed consent.
- •Subject is willing and able to comply with the investigational plan requirements.
- •Subjects with a pre-operative Lund-MacKay stage of 6 (≥3 per nostril).
- •Subject with a pre-operative Lund-Mackay stage side-to-side difference ≤
- •Subject of child-bearing potential is not pregnant and agrees to not become pregnant during the course of the study.
排除标准
- •Subject with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
- •Subject with an underlying systemic disorders known to affect the nose (e.g., Wegener's granulomatosis, sarcoidosis, Churg-Strauss syndrome, or other systemic vasculitides).
- •Subject with any bleeding disorder or use of medication increasing bleeding risk, except low-dose aspirin.
- •Subject with a known or suspected allergy to device components.
- •Subject with known hemophilia.
- •Subject with insulin dependent diabetes.
- •Subject with an oral steroid dependent condition.
- •Subject with glaucoma, ocular hypertension, posterior subcapsular cataracts.
- •Subject with a (previous) diagnosis of Samter's Triad (AERD).
- •Subject that requires nasal ointments or creams at time of device placement.
- •Subject with a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data.
- •Subject with plans to (or otherwise anticipate the need to) undergo an ENT procedure within the 90-day study follow-up.
- •Subject participating in another clinical research study (within 30 days prior to screening up to 90 days post-operative).
- •Subject that used any form of biologics within 90 days prior to sinus surgery and during follow-up to day
- •Subject that used any form of corticosteroid within 2 weeks prior to sinus surgery.
研究组 & 干预措施
OCEAN
Experimental
Application after nasal/sinus surgery
干预措施: OCEAN (Device)
Steroid-eluting Sinus Stent
Active Comparator
Application after nasal/sinus surgery
干预措施: Steroid-eluting sinus stent (Device)
结局指标
主要结局
Rate of Serious Adverse Events
时间窗: Up to Day 25
Rate of serious adverse events related to the use of OCEAN bioresorbable nasal dressing.
Endoscopic Assessment
时间窗: Day 25
Endoscopic assessment of wound healing to compare test-treated and control-treated cavities.
次要结局
- Endoscopic Evaluation of Sinonasal Cavities(Days 25 and 90)
- Rate of Adverse Events(Up to Day 90)
- Rate of post-operative interventions(Up to Day 25 and Day 90)
研究者
研究点 (9)
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