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

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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Recruitment Status : Withdrawn (Covid-19)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

Tracking Information
First Submitted Date  ICMJE November 5, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • 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
  • 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
  • Need for surgical intervention [ Time Frame: day 14, week 6, 12 and at 6, 9 and 12 months ]
    Capture surgical intervention
  • 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
  • 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
  • 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
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 6, 2019)
  • Saccharine test [ Time Frame: day 0, week 6, 12 weeks and at 12 months ]
    Evaluate muco-ciliary clearance time
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Rhinosinusitis Without Nasal Polyps
Intervention  ICMJE Device: Vibration Therapy
SDX-3101 is used for drug-free treatment of CRSsNP in adults.
Study Arms  ICMJE
  • Experimental: Treatment
    The applied therapeutic vibrations generated by an acoustic coil have a defined sweeping frequency range.
    Intervention: Device: Vibration Therapy
  • Active Comparator: Control
    A control device with a different vibration pattern will be used as comparator intervention
    Intervention: Device: Vibration Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 20, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2019)
76
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04158596
Other Study ID Numbers  ICMJE SDX-3101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SynDermix AG
Study Sponsor  ICMJE SynDermix AG
Collaborators  ICMJE ISS AG
Investigators  ICMJE
Study Director: Carlos R Camozzi, MD SynDermix AG
PRS Account SynDermix AG
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP