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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158596
Recruitment Status : Withdrawn (Covid-19)
First Posted : November 12, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
ISS AG
Information provided by (Responsible Party):
SynDermix AG

Study Description
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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

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Without Nasal Polyps Device: Vibration Therapy Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
The applied therapeutic vibrations generated by an acoustic coil have a defined sweeping frequency range.
 Device: Vibration Therapy
SDX-3101 is used for drug-free treatment of CRSsNP in adults.
Active Comparator: Control
A control device with a different vibration pattern will be used as comparator intervention
 Device: Vibration Therapy
SDX-3101 is used for drug-free treatment of CRSsNP in adults.


Outcome Measures
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Primary Outcome Measures :
  1. SNOT-20 GAV [ Time Frame: 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 :
  1. Lund-Kennedy Score [ Time Frame: 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

  2. Overall disease control [ Time Frame: day 14, week 6, 12 and at 6, 9 and 12 months ]
    Need for systemic medication, steroid or antibiotic, number of days

  3. Need for surgical intervention [ Time Frame: day 14, week 6, 12 and at 6, 9 and 12 months ]
    Capture surgical intervention

  4. Ability to perform normal activities [ Time Frame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months, ]
    Measured with the SNOT-20 GAV

  5. Acceptability of treatment [ Time Frame: 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

  6. Overall score SNOT-20 [ Time Frame: 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

  7. Pain in the face [ Time Frame: 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)

  8. Global impression by investigator [ Time Frame: day 0, week 6, 12 and at 12 months, ]
    Measured with Visual Analogue Scale 0 to 10, 0 is unsatisfactory 10 is optimal outcome


Other Outcome Measures:
  1. Saccharine test [ Time Frame: day 0, week 6, 12 weeks and at 12 months ]
    Evaluate muco-ciliary clearance time

  2. Reduction in inflammatory markers [ Time Frame: day 0, day 14, week 6, 12 ]
    Assessed by Biomarkers: IL-1β, IL-2, IL-4, IL-10, IL-12 and IgE in nasal secretion

  3. Exhaled nasal Nitric Oxide (nNO) levels [ Time Frame: day 0, day 14, week 6, 12 and 12 months ]
    only in a subpopulation in selected site/s


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158596


Locations
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Austria
Kardinal Schwarzenberg Klinikum GmbH
Schwarzach im Pongau, Austria, 5620
Germany
Praxis Dr.med. Decot
Dreieich, Germany, 63303
ENT Research Institut für Klinische Studien
Essen, Germany, 45355
HNO Praxis am Neckar
Heidelberg, Germany, 69120
HNO - Arzt Allergologe Studienzentrum
Viernheim, Germany, 68519
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany, 42283
Switzerland
Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Kopf- und Halschirurgie, Inselspital,
Bern, Switzerland, 3010
Department of ENT, Head and Neck Surgery Universitätsspital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
SynDermix AG
ISS AG
Investigators
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Study Director: Carlos R Camozzi, MD SynDermix AG
More Information
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Responsible Party: SynDermix AG
ClinicalTrials.gov Identifier: NCT04158596    
Other Study ID Numbers: SDX-3101
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Respiratory Tract Infections
 Infections
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases