Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Safety
研究概览
简要总结
The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in patients undergoing nasal/sinus surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •Patient is 18 years or older
- •Patient is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitis with nasal polyps (CRSwNP) or Chronic Rhinosinusitis without nasal polyps (CRSsNP)
- •Patient is willing and able to comply with all study elements as indicated by their written informed consent
- •Patients with a pre-operative Lund-MacKay score of ≥ 6.
排除标准
- •Patient is pregnant or nursing
- •Patients with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months
- •Patients with a platelet disorder
- •Patients with a known or suspected allergy to device components
- •Patients with known hemophilia
- •Patients with insulin dependent diabetics
- •Patients with an oral steroid dependent condition
- •Patients with glaucoma, ocular hypertension, posterior subcapsular cataracts
- •Patients with a (previous) diagnosis of Samter's Triad (aspirin-exacerbated respiratory disease (AERD))
- •Patients that require nasal ointments or creams at time of device placement
- •Patients with a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data
- •Patients with plans to (or otherwise anticipate the need to) undergo an ear, nose, throat (ENT) procedure within the 90 day study follow up
- •Patients participating in another clinical research study (within 30 days prior to screening up till 90 days post-operative).
- •Patients that used any form of corticosteroid or immunologics within 2 weeks prior to sinus surgery or during follow-up to day 30.
研究组 & 干预措施
OCEAN
Application of OCEAN after nasal/sinus surgery
干预措施: OCEAN (Device)
结局指标
主要结局
Safety
时间窗: Up to 25 days after surgery
Rate of serious adverse events related to the use of the OCEAN bioresorbable nasal dressing post nasal surgery
Performance
时间窗: Up to 25 days after surgery
Endoscopic evaluation of aspects of wound healing as assessed using the Lund-Kennedy Endoscopic Score System (LKS). The LKS assesses various factors like edema, crusting, discharge, polyps, and mucosal inflammation. Each parameter is scored from 0 to 2, with 0 being normal and 2 representing severe findings. Higher scores on the Lund-Kennedy Scale indicate a worse outcome, reflecting more severe disease or poor wound healing. Minimum Value: 0 (This represents no signs of inflammation or disease); Maximum Value: 20 (This indicates the most severe signs of disease or inflammation)
Rate of Serious Adverse Events
时间窗: Up to 25 days after surgery
Rate of serious adverse events related to the use of the OCEAN bioresorbable nasal dressing post nasal surgery
次要结局
未报告次要终点