NCT06020690招募中不适用
A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis
Enlight Medical Technologies (Shanghai) Co., Ltd1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2023年8月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- non reintervention rate
研究概览
简要总结
The goal of this clinical trial is to learn about the safety and effectiveness of Novabel bioabsorbable steroid-releasing stent in chronic sinusitis. The main questions it aims to answer are:
- The safety of this device for the chronic sinusitis
- The effectiveness of this device for the chronic sinusitis Participants will be implanted bioabsorbable steroid-releasing stents after FESS surgery. Participants will be asked to be back to the clinic for follow-up 14 days, 30 days, 90 days, 180 days and 360 days after procedure.
Researchers will compare test device and marketed device to see if the safety and effectiveness between these two devices are non-inferior.
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
- •Diagnose with CRS based on Chinese guidelines for diagnosis and treatment of chronic rhinosinusitis (2018), who were scheduled to undergo primary or revision bilateral ESS.
- •Have evidence of bilateral sinus based on computed tomographic (CT) scan (Lund-Mackay [L-M] score of <=3 on each side).
- •Can understand the purpose of this study and will to join and finish all the follow up according to the study. Sign the ICF.
排除标准
- •Know history of allergy or intolerance to corticosteroids or mometasone furoate.
- •The subject has a known allergic reaction or contraindication to the device material and its degradation products (L-polylactic acid, racemic polylactic acid, lactide lactate, lactic acid).
- •Clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors.
- •Clinical evidence of acute bacterial sinusitis or suspicion of invasive fungal sinusitis.
- •Glaucoma, ocular hypertension, posterior subcapsular cataracts.
- •Known history of immune deficiency or concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease.
- •Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 360 day follow-up period.
- •Current ESS including frontal sinus surgery is aborted for any reason.
- •Pregnant or lactating female
- •Investigator determination that the potential study subject is unable to comply with study procedures and/or follow-up, or provided informed consent.
- •Currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of the clinical study.
结局指标
主要结局
non reintervention rate
时间窗: 30 days
The need for postoperative interventions, medical and surgical, as determined based on review of video endoscopic findings by an independent blinded surgeon.
次要结局
- sinus panty rate(30 days, 90 days, 180 days and 1 year)
- Lund-Kennedy score(30 days, 90 days, 180 days and 1 year)
- Lund-Mackay score(90 days)
- VAS score(30 days, 90 days, 180 days and 1 year)
- implantation successful rate(immediately after the procedure)
研究者
研究点 (1)
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