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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinus irrigation | Experimental | Sinus irrigation intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SinuSafe Medical Device for Maxillary Sinus | Device | Sinus lavage via the natural sinus ostium, without ostial dilation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Presence of adverse events | Within day 1 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Avinoam Gemer | Contact | 972-544-858822 | avinoamgemer@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Itzhak Braverman, Professor | Hillel Yaffe Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D015523 | Maxillary Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| 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 |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |