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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Sinus lavage via the natural sinus ostium, without ostial dilation.
Adverse events
Presence of adverse events
Time frame: Within day 1
Mucosal damage visual inspection
Visual inspection of sinus mucosa with the endoscope looking for mucosal damage.
Time frame: 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.
Time frame: Within 1 hour
Pain during procedure
Pain during procedure with the VAS pain scale
Time frame: Within 1 hour
Usability & Tolerability Questionnaire
Usability \& Tolerability Questionnaire
Time frame: Within 1 hour
Mucus leftovers visual inspection
Visual inspection of sinus mucosa with the endoscope looking for mucus leftovers
Time frame: Within 1 hour
Mucus aspiration into the syringe
Mucus aspiration into the syringe (yes/ no and time)
Time frame: Within 1 hour
Pain relief
Pain relief in the post-treatment VAS pain scale
Time frame: Within 1 hour
Time measurements of cannula insertion.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time measurements of cannula insertion
Time frame: Within 1 hour
Time measurements of irrigation and aspiration
Time measurements of irrigation and aspiration
Time frame: Within 1 hour
SNOT 20 questionnaire
SNOT 20 questionnaire (Hebrew version) to evaluate the patient's severity level before the treatment
Time frame: Within 1 hour