Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

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

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

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

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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