Chronic Rhinosinusitis Without Nasal PolypsSDX-3101NCT04158596
Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
A study testing Vibration Therapy in people with Chronic Rhinosinusitis Without Nasal Polyps, run by SynDermix AG at 8 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Rhinosinusitis Without Nasal Polyps
- What is being tested?
- Vibration Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 1 Jun 2020to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany5 sites
Praxis Dr.med. Decot
Dreieich, 63303
ENT Research Institut für Klinische Studien
Essen, 45355
HNO Praxis am Neckar
Heidelberg, 69120
HNO - Arzt Allergologe Studienzentrum
Viernheim, 68519
Helios Universitätsklinikum Wuppertal
Wuppertal, 42283
Switzerland2 sites
Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten, Kopf- und Halschirurgie, Inselspital,
Bern, 3010
Department of ENT, Head and Neck Surgery Universitätsspital Zürich
Zurich, 8091
About this study
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
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
Read the 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
- Being tested
- Vibration Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration TherapyDevice
SDX-3101 is used for drug-free treatment of CRSsNP in adults.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The applied therapeutic vibrations generated by an acoustic coil have a defined sweeping frequency range. Receives: Device: Vibration Therapy |
| Control | Active comparator | A control device with a different vibration pattern will be used as comparator intervention Receives: Device: Vibration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (8)
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
Measured: day 0, day 14, week 6, 12 and at 6, 9 and 12 months
Overall disease control
Need for systemic medication, steroid or antibiotic, number of days
Measured: day 14, week 6, 12 and at 6, 9 and 12 months
Need for surgical intervention
Capture surgical intervention
Measured: day 14, week 6, 12 and at 6, 9 and 12 months
Ability to perform normal activities
Measured with the SNOT-20 GAV
Measured: day 0, day 14, week 6, 12 and at 6, 9 and 12 months,
Acceptability of treatment
Measurement of Visual Analogue Scale 0 to 5, 0 is unacceptable to 5 fully accepted
Measured: day 14, week 6, 12 and at 6, 9 and 12 months
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
Measured: day 0, day 14, week 6, 12 and at 6, 9 and 12 months
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)
Measured: day 0, day 14, week 6, 12 and at 6, 9 and 12 months
Global impression by investigator
Measured with Visual Analogue Scale 0 to 10, 0 is unsatisfactory 10 is optimal outcome
Measured: day 0, week 6, 12 and at 12 months,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start1 Jun 2020
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2021 (estimated)
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis Without Nasal PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SynDermix AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ISS AG
- Responsible party
- Sponsor
- Investigators
- Carlos R Camozzi, MD, Study director, SynDermix AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158596
- Sponsor's protocol ID
- SDX-3101
- Acronym
- SDX-3101
- Status last verified
- Oct 2020
- First submitted
- 5 Nov 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04158596
- Acronym / sponsor ID
- SDX-3101 / SDX-3101
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SynDermix AGIndustry (pharma, biotech, devices)
- Collaborators
- ISS AG
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Vibration TherapyThe applied therapeutic vibrations generated by an acoustic coil have a defined sweeping frequency range. |
| Control | Active comparator | Device: Vibration TherapyA control device with a different vibration pattern will be used as comparator intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration TherapySDX-3101 is used for drug-free treatment of CRSsNP in adults. | Device | Control, Treatment |
Primary outcome
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.
8 secondary outcomes
Lund-Kennedy Score
Time frame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months
Overall disease control
Time frame: day 14, week 6, 12 and at 6, 9 and 12 months
Need for surgical intervention
Time frame: day 14, week 6, 12 and at 6, 9 and 12 months
Ability to perform normal activities
Time frame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months,
Acceptability of treatment
Time frame: day 14, week 6, 12 and at 6, 9 and 12 months
Overall score SNOT-20
Time frame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months
Pain in the face
Time frame: day 0, day 14, week 6, 12 and at 6, 9 and 12 months
Global impression by investigator
Time frame: day 0, week 6, 12 and at 12 months,
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos R Camozzi, MD study director
SynDermix AG
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration Therapy in people with Chronic Rhinosinusitis Without Nasal Polyps, run by SynDermix AG at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNOT-20 GAV (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.