Study Designed to Clinically Evaluate Sinus Wash Device Prototypes

Study Overview
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Brief Summary
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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

Official Title
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Pilot Study Designed to Clinically Evaluate Sinus Wash Device Prototypes in Patients With Sinusitis During Endoscopic Sinus Surgery (ESS) and in the Hospital Outpatient

Conditions
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Sinusitis, Maxillary Sinusitis

Intervention / Treatment
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* Device: SinuSafe Medical Device for Maxillary Sinus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sinus irrigation<br>Sinus irrigation intervention | Device: SinuSafe Medical Device for Maxillary Sinus<br>* Sinus lavage via the natural sinus ostium, without ostial dilation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Presence of adverse events | Within day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal damage visual inspection | Visual inspection of sinus mucosa with the endoscope looking for mucosal damage. | 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. | Within 1 hour | 
| Pain during procedure | Pain during procedure with the VAS pain scale | Within 1 hour | 
| Usability & Tolerability Questionnaire | Usability & Tolerability Questionnaire | Within 1 hour | 
| Mucus leftovers visual inspection | Visual inspection of sinus mucosa with the endoscope looking for mucus leftovers | Within 1 hour | 
| Mucus aspiration into the syringe | Mucus aspiration into the syringe (yes/ no and time) | Within 1 hour | 
| Pain relief | Pain relief in the post-treatment VAS pain scale | Within 1 hour | 
| Time measurements of cannula insertion. | Time measurements of cannula insertion | Within 1 hour | 
| Time measurements of irrigation and aspiration | Time measurements of irrigation and aspiration | Within 1 hour | 
| SNOT 20 questionnaire | SNOT 20 questionnaire (Hebrew version) to evaluate the patient's severity level before the treatment | Within 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sinus wash, sinus lavage, Sinusitis