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 ]

Presence of adverse events


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