Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps
- Interventions
- Device: Vibration Therapy
- Registration Number
- NCT04158596
- Lead Sponsor
- SynDermix AG
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Vibration Therapy The applied therapeutic vibrations generated by an acoustic coil have a defined sweeping frequency range. Control Vibration Therapy A control device with a different vibration pattern will be used as comparator intervention
- Primary Outcome Measures
Name Time Method SNOT-20 GAV 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.
- Secondary Outcome Measures
Name Time Method Overall disease control day 14, week 6, 12 and at 6, 9 and 12 months Need for systemic medication, steroid or antibiotic, number of days
Lund-Kennedy Score day 0, day 14, week 6, 12 and at 6, 9 and 12 months We use the Lund-Kennedy endoscopic scoring system to measure the patient's nasal cavity based on there were edema, vesicles, adhesions, scars and polyps
Need for surgical intervention day 14, week 6, 12 and at 6, 9 and 12 months Capture surgical intervention
Ability to perform normal activities day 0, day 14, week 6, 12 and at 6, 9 and 12 months, Measured with the SNOT-20 GAV
Acceptability of treatment day 14, week 6, 12 and at 6, 9 and 12 months Measurement of Visual Analogue Scale 0 to 5, 0 is unacceptable to 5 fully accepted
Overall score SNOT-20 day 0, day 14, week 6, 12 and at 6, 9 and 12 months The SNOT-20 has a maximum score of 100 and a minimum score of 0. Higher values represent a worse outcome
Global impression by investigator day 0, week 6, 12 and at 12 months, Measured with Visual Analogue Scale 0 to 10, 0 is unsatisfactory 10 is optimal outcome
Pain in the face day 0, day 14, week 6, 12 and at 6, 9 and 12 months Measured on a 4-point scale, (0=no symptoms; 1=mild symptoms present, but not troublesome; 2=moderate symptoms that were frequently troublesome but not sufficiently so to interfere with normal daily activities or sleep; 3=severe symptoms that interfered with normal daily activities or sleep)
Trial Locations
- Locations (8)
Helios Universitätsklinikum Wuppertal
🇩🇪Wuppertal, Germany
Kardinal Schwarzenberg Klinikum GmbH
🇦🇹Schwarzach im Pongau, Austria
Praxis Dr.med. Decot
🇩🇪Dreieich, Germany
Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Kopf- und Halschirurgie, Inselspital,
🇨🇭Bern, Switzerland
HNO - Arzt Allergologe Studienzentrum
🇩🇪Viernheim, Germany
Department of ENT, Head and Neck Surgery Universitätsspital Zürich
🇨🇭Zürich, Switzerland
ENT Research Institut für Klinische Studien
🇩🇪Essen, Germany
HNO Praxis am Neckar
🇩🇪Heidelberg, Germany