Clinical Trial: Study Designed to Clinically Evaluate Sinus Wash Device Prototypes
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
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
Brief 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
Detailed Summary:
Sponsor: SinuSafe Medical LTD
Current Primary Outcome: Adverse events [ Time Frame: Within day 1 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: SinuSafe Medical LTD
Dates:
Date Received: September 13, 2016
Date Started: January 2017
Date Completion: January 2020
Last Updated: October 10, 2016
Last Verified: October 2016