Randomised, Double-blind, Multi-centre, Clinical Trial to Assess the Safety and Efficacy of SDX-3101, an Innovative Vibration Therapy Portable Device for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 16
- 主要终点
- SNOT-20 GAV
研究概览
简要总结
The purpose of this clinical trial is to assess the safety and efficacy of SDX-3101 for treatment of adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by investigating a vibration pattern of SDX-3101 compared to a control
详细描述
Chronic rhinosinusitis (CRS) is a common disease (e.g. 11% of adults in the UK report symptoms of CRS) leading to substantial health and socioeconomic burden with estimated healthcare costs in the USA of $772/patient/year (2011).
CRS is characterised by the long-term presence of multiple symptoms including facial pain/pressure in about 80% of CRS patients. Factors contributing to the pathophysiology of adult CRS include allergies, bacterial biofilms, asthma and exposure to various environmental pollutants. Computed tomography (CT) scans are often used to identify mucosal thickening and to identify any comorbid factors such as anatomic abnormalities.
It is known from the literature that low vibration frequency can improve blood flow, significantly reduce inflammation, and increase the fibroblast activity [13]. Therefore, SynDermix AG created the innovative high-technology, portable medical device SDX-3101 targeting a disease with high unmet medical need. The device offers a drug-free or eventually an add on treatment complying with the maximum demands of safety for the patients potentially avoiding undesirable drug effects or surgery. SDX-3101 is indicated for treatment of CRSsNP in adults
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female subjects between 18 and 70 years old
- •Diagnosed history of chronic rhinosinusitis without nasal polyps (CRSsNP) defined as per EPOS Guidelines.
- •Moderate to severe baseline SNOT-20 GAV score (> 20)
- •Willingness to stop nasal saline irrigation and drug therapy for CRSsNP (restart later on possible)
排除标准
- •Subjects with local pathology that would compromise the ability to either administer the device or assess the benefits/risks (e.g. mucocele, antrochoanal polyp, facial trauma, radiation injury, or birth defect)
- •Systemic corticosteroids if not stop for 14 days before study enrolment
- •Subjects suffering from insufficiently controlled asthma
- •Subjects suffering from insufficiently controlled allergic rhinitis (AR)
- •Subjects with prior sinus operations within the last 4 months
- •Subjects with known primary ciliary dyskinesia/cystic fibrosis
- •Subjects with serious underlying medical condition
- •Ongoing oncological treatments
- •Known hypersensitivity to materials in direct contact with the skin
- •Metal or metal-like implant (incl. ceramic) located in the head or neck area. Unremovable hearing aids
- •Patients with implanted cardiac pace-maker
- •Women who are pregnant or breast feeding
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
结局指标
主要结局
SNOT-20 GAV
时间窗: 12 weeks
The primary endpoint is the change in subjective symptoms as quantified by the German validated disease-specific 20-item Sino-nasal Outcome Test (SNOT-20 GAV) after 12 weeks. Superiority is defined as more than minimal clinically important difference (MCID) of 8.9 points to active control of SNOT-20 score at 12 weeks.
次要结局
- Overall disease control(day 14, week 6, 12 and at 6, 9 and 12 months)
- Lund-Kennedy Score(day 0, day 14, week 6, 12 and at 6, 9 and 12 months)
- Need for surgical intervention(day 14, week 6, 12 and at 6, 9 and 12 months)
- Ability to perform normal activities(day 0, day 14, week 6, 12 and at 6, 9 and 12 months,)
- Acceptability of treatment(day 14, week 6, 12 and at 6, 9 and 12 months)
- Overall score SNOT-20(day 0, day 14, week 6, 12 and at 6, 9 and 12 months)
- Global impression by investigator(day 0, week 6, 12 and at 12 months,)
- Pain in the face(day 0, day 14, week 6, 12 and at 6, 9 and 12 months)