SinusitisNCT02931604
Study Designed to Clinically Evaluate Sinus Wash Device Prototypes
A study testing SinuSafe Medical Device for Maxillary Sinus in people with Sinusitis and Maxillary Sinusitis, run by SinuSafe Medical LTD.
Trial summary
The purpose of this study is to clinically evaluate sinus wash device prototypes in patients with sinusitis during Endoscopic Sinus Surgery (ESS) and in the hospital outpatient Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sinusitis, Maxillary Sinusitis
- What is being tested?
- SinuSafe Medical Device for Maxillary Sinus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-65 years of age.
- Signs and symptoms of acute exacerbation during chronic maxillary sinusitis.
- Pain higher than 5 in VAS of 0-10.
- Able to understand and provide written informed consent.
Who cannot join
- Patients who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by medical history based on the opinion of the investigator.
- Extensive sinonasal polyps that may interfere with the treatment procedure.
- Previous sinonasal surgery.
- Acute exacerbation of sinusitis in the frontal or sphenoid sinuses.
- Sinonasal osteoneogenesis.
- Cystic fibrosis.
Show all 19Show fewer
- Sinonasal tumors or obstructive lesions.
- Presence of features consistent with sinus fungal disease on CT or physical examination.
- History of facial trauma that distorted the sinus anatomy.
- Ciliary dysfunction.
- History of insulin dependent diabetes.
- Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio (INR) is below 1.5.
- Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure.
- Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure.
- Pregnancy.
- Psychiatric disease.
- Currently participating in other drug or device studies.
- Investigator's opinion that the subject should not be in the study such as any conditions that could compromise the wellbeing of the patient or integrity of the study or prevent the patient from meeting or performing study requirements.
- Patient is not capable of following the study schedule for any reason.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study Designed to Clinically Evaluate Sinus Wash Device Prototypes in Patients With Sinusitis During Endoscopic Sinus Surgery (ESS) and in the Hospital Outpatient
The purpose of this study is to clinically evaluate sinus wash device prototypes in patients with sinusitis during Endoscopic Sinus Surgery (ESS) and in the hospital outpatient
- Conditions
- Sinusitis, Maxillary Sinusitis
- Being tested
- SinuSafe Medical Device for Maxillary Sinus
- Keywords
- sinus wash, sinus lavage, Sinusitis
- Medical subject headings
- Sinusitis, Maxillary Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinuSafe Medical Device for Maxillary SinusDevice
Sinus lavage via the natural sinus ostium, without ostial dilation.
| Study group | Role | What they receive |
|---|---|---|
| Sinus irrigation | Experimental | Sinus irrigation intervention Receives: Device: SinuSafe Medical Device for Maxillary Sinus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Presence of adverse events
Measured: Within day 1
Secondary outcomes (10)
Mucosal damage visual inspection
Visual inspection of sinus mucosa with the endoscope looking for mucosal damage.
Measured: Within 1 hour
Syringe visual inspection
Visual inspection of the aspirated liquids looking for bleeding. Excess nasal bleeding shall be defined as a doctor decision to use sinus or nasal packing.
Measured: Within 1 hour
Pain during procedure
Pain during procedure with the VAS pain scale
Measured: Within 1 hour
Usability & Tolerability Questionnaire
Usability \& Tolerability Questionnaire
Measured: Within 1 hour
Mucus leftovers visual inspection
Visual inspection of sinus mucosa with the endoscope looking for mucus leftovers
Measured: Within 1 hour
Mucus aspiration into the syringe
Mucus aspiration into the syringe (yes/ no and time)
Measured: Within 1 hour
Pain relief
Pain relief in the post-treatment VAS pain scale
Measured: Within 1 hour
Time measurements of cannula insertion.
Time measurements of cannula insertion
Measured: Within 1 hour
Time measurements of irrigation and aspiration
Time measurements of irrigation and aspiration
Measured: Within 1 hour
SNOT 20 questionnaire
SNOT 20 questionnaire (Hebrew version) to evaluate the patient's severity level before the treatment
Measured: Within 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SinuSafe Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Itzhak Braverman, Professor, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931604
- Sponsor's protocol ID
- SNS001
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Designed to Clinically Evaluate Sinus Wash Device Prototypes in Patients With Sinusitis During Endoscopic Sinus Surgery (ESS) and in the Hospital Outpatient
- ClinicalTrials.gov ID
- NCT02931604
- Acronym / sponsor ID
- SNS001
- Conditions
- Sinusitis, Maxillary Sinusitis
- Keywords
- sinus wash, sinus lavage, Sinusitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SinuSafe Medical LTDIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- 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 study is to clinically evaluate sinus wash device prototypes in patients with sinusitis during Endoscopic Sinus Surgery (ESS) and in the hospital outpatient
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinus irrigation | Experimental | Device: SinuSafe Medical Device for Maxillary SinusSinus irrigation intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, 18-65 years of age.
- Signs and symptoms of acute exacerbation during chronic maxillary sinusitis.
- Pain higher than 5 in VAS of 0-10.
- Able to understand and provide written informed consent.
Key exclusion criteria (19 listed)
- Patients who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by medical history based on the opinion of the investigator.
- Extensive sinonasal polyps that may interfere with the treatment procedure.
- Previous sinonasal surgery.
- Acute exacerbation of sinusitis in the frontal or sphenoid sinuses.
- Sinonasal osteoneogenesis.
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 |
|---|---|---|
| SinuSafe Medical Device for Maxillary SinusSinus lavage via the natural sinus ostium, without ostial dilation. | Device | Sinus irrigation |
Primary outcome
Adverse events
Time frame: Within day 1
Presence of adverse events
10 secondary outcomes
Mucosal damage visual inspection
Time frame: Within 1 hour
Syringe visual inspection
Time frame: Within 1 hour
Pain during procedure
Time frame: Within 1 hour
Usability & Tolerability Questionnaire
Time frame: Within 1 hour
Mucus leftovers visual inspection
Time frame: Within 1 hour
Mucus aspiration into the syringe
Time frame: Within 1 hour
Pain relief
Time frame: Within 1 hour
Time measurements of cannula insertion.
Time frame: Within 1 hour
Time measurements of irrigation and aspiration
Time frame: Within 1 hour
SNOT 20 questionnaire
Time frame: Within 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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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.
Itzhak Braverman, Professor principal investigator
Hillel Yaffe Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing SinuSafe Medical Device for Maxillary Sinus in people with Sinusitis and Maxillary Sinusitis, run by SinuSafe Medical LTD.
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 19 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: status not confirmed, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avinoam Gemer (972-544-858822, avinoamgemer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Within day 1). 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 13 Oct 2016.