Back to resultsSafety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) (SDX-3101)
Primary Purpose
Chronic Rhinosinusitis Without Nasal Polyps
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vibration Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis Without Nasal Polyps
Eligibility 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
Sites / Locations
- Kardinal Schwarzenberg Klinikum GmbH
- Praxis Dr.med. Decot
- ENT Research Institut für Klinische Studien
- HNO Praxis am Neckar
- HNO - Arzt Allergologe Studienzentrum
- Helios Universitätsklinikum Wuppertal
- Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Kopf- und Halschirurgie, Inselspital,
- Department of ENT, Head and Neck Surgery Universitätsspital Zürich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control
Arm Description
The applied therapeutic vibrations generated by an acoustic coil have a defined sweeping frequency range.
A control device with a different vibration pattern will be used as comparator intervention
Outcomes
Primary Outcome Measures
SNOT-20 GAV
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
Lund-Kennedy Score
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
Need for systemic medication, steroid or antibiotic, number of days
Need for surgical intervention
Capture surgical intervention
Ability to perform normal activities
Measured with the SNOT-20 GAV
Acceptability of treatment
Measurement of Visual Analogue Scale 0 to 5, 0 is unacceptable to 5 fully accepted
Overall score SNOT-20
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
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
Measured with Visual Analogue Scale 0 to 10, 0 is unsatisfactory 10 is optimal outcome
Full Information
NCT ID
NCT04158596
First Posted
November 5, 2019
Last Updated
October 20, 2020
Sponsor
SynDermix AG
Collaborators
ISS AG
1. Study Identification
Unique Protocol Identification Number
NCT04158596
Brief Title
Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Acronym
SDX-3101
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Covid-19
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SynDermix AG
Collaborators
ISS AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis Without Nasal Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
The applied therapeutic vibrations generated by an acoustic coil have a defined sweeping frequency range.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
A control device with a different vibration pattern will be used as comparator intervention
Intervention Type
Device
Intervention Name(s)
Vibration Therapy
Intervention Description
SDX-3101 is used for drug-free treatment of CRSsNP in adults.
Primary Outcome Measure Information:
Title
SNOT-20 GAV
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Lund-Kennedy Score
Description
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
Time Frame
day 0, day 14, week 6, 12 and at 6, 9 and 12 months
Title
Overall disease control
Description
Need for systemic medication, steroid or antibiotic, number of days
Time Frame
day 14, week 6, 12 and at 6, 9 and 12 months
Title
Need for surgical intervention
Description
Capture surgical intervention
Time Frame
day 14, week 6, 12 and at 6, 9 and 12 months
Title
Ability to perform normal activities
Description
Measured with the SNOT-20 GAV
Time Frame
day 0, day 14, week 6, 12 and at 6, 9 and 12 months,
Title
Acceptability of treatment
Description
Measurement of Visual Analogue Scale 0 to 5, 0 is unacceptable to 5 fully accepted
Time Frame
day 14, week 6, 12 and at 6, 9 and 12 months
Title
Overall score SNOT-20
Description
The SNOT-20 has a maximum score of 100 and a minimum score of 0. Higher values represent a worse outcome
Time Frame
day 0, day 14, week 6, 12 and at 6, 9 and 12 months
Title
Pain in the face
Description
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)
Time Frame
day 0, day 14, week 6, 12 and at 6, 9 and 12 months
Title
Global impression by investigator
Description
Measured with Visual Analogue Scale 0 to 10, 0 is unsatisfactory 10 is optimal outcome
Time Frame
day 0, week 6, 12 and at 12 months,
Other Pre-specified Outcome Measures:
Title
Saccharine test
Description
Evaluate muco-ciliary clearance time
Time Frame
day 0, week 6, 12 weeks and at 12 months
Title
Reduction in inflammatory markers
Description
Assessed by Biomarkers: IL-1β, IL-2, IL-4, IL-10, IL-12 and IgE in nasal secretion
Time Frame
day 0, day 14, week 6, 12
Title
Exhaled nasal Nitric Oxide (nNO) levels
Description
only in a subpopulation in selected site/s
Time Frame
day 0, day 14, week 6, 12 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos R Camozzi, MD
Organizational Affiliation
SynDermix AG
Official's Role
Study Director
Facility Information:
Facility Name
Kardinal Schwarzenberg Klinikum GmbH
City
Schwarzach im Pongau
ZIP/Postal Code
5620
Country
Austria
Facility Name
Praxis Dr.med. Decot
City
Dreieich
ZIP/Postal Code
63303
Country
Germany
Facility Name
ENT Research Institut für Klinische Studien
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
HNO Praxis am Neckar
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
HNO - Arzt Allergologe Studienzentrum
City
Viernheim
ZIP/Postal Code
68519
Country
Germany
Facility Name
Helios Universitätsklinikum Wuppertal
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Kopf- und Halschirurgie, Inselspital,
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Department of ENT, Head and Neck Surgery Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
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