Study Designed to Clinically Evaluate Sinus Wash Device Prototypes
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|ClinicalTrials.gov Identifier: NCT02931604|
Recruitment Status : Unknown
Verified October 2016 by SinuSafe Medical LTD.
Recruitment status was: Not yet recruiting
First Posted : October 13, 2016
Last Update Posted : October 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis Maxillary Sinusitis||Device: SinuSafe Medical Device for Maxillary Sinus||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Sinus irrigation
Sinus irrigation intervention
Device: SinuSafe Medical Device for Maxillary Sinus
Sinus lavage via the natural sinus ostium, without ostial dilation.
- Adverse events [ Time Frame: Within day 1 ]Presence of adverse events
- Mucosal damage visual inspection [ Time Frame: Within 1 hour ]Visual inspection of sinus mucosa with the endoscope looking for mucosal damage.
- Syringe visual inspection [ Time Frame: Within 1 hour ]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.
- Pain during procedure [ Time Frame: Within 1 hour ]Pain during procedure with the VAS pain scale
- Usability & Tolerability Questionnaire [ Time Frame: Within 1 hour ]Usability & Tolerability Questionnaire
- Mucus leftovers visual inspection [ Time Frame: Within 1 hour ]Visual inspection of sinus mucosa with the endoscope looking for mucus leftovers
- Mucus aspiration into the syringe [ Time Frame: Within 1 hour ]Mucus aspiration into the syringe (yes/ no and time)
- Pain relief [ Time Frame: Within 1 hour ]Pain relief in the post-treatment VAS pain scale
- Time measurements of cannula insertion. [ Time Frame: Within 1 hour ]Time measurements of cannula insertion
- Time measurements of irrigation and aspiration [ Time Frame: Within 1 hour ]Time measurements of irrigation and aspiration
- SNOT 20 questionnaire [ Time Frame: Within 1 hour ]SNOT 20 questionnaire (Hebrew version) to evaluate the patient's severity level before the treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931604
|Contact: Avinoam Gemeremail@example.com|
|Principal Investigator:||Itzhak Braverman, Professor||Hillel Yaffe Medical Center|