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Study Designed to Clinically Evaluate Sinus Wash Device Prototypes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
SinuSafe Medical LTD

Tracking Information
First Submitted Date  ICMJE September 13, 2016
First Posted Date  ICMJE October 13, 2016
Last Update Posted Date October 13, 2016
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
Adverse events [ Time Frame: Within day 1 ]
Presence of adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Designed to Clinically Evaluate Sinus Wash Device Prototypes
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sinusitis
  • Maxillary Sinusitis
Intervention  ICMJE Device: SinuSafe Medical Device for Maxillary Sinus
Sinus lavage via the natural sinus ostium, without ostial dilation.
Study Arms  ICMJE Experimental: Sinus irrigation
Sinus irrigation intervention
Intervention: Device: SinuSafe Medical Device for Maxillary Sinus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 10, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, 18-65 years of age.
  2. Signs and symptoms of acute exacerbation during chronic maxillary sinusitis.
  3. Pain higher than 5 in VAS of 0-10.
  4. Able to understand and provide written informed consent.

Exclusion Criteria:

  1. Patients who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by medical history based on the opinion of the investigator.
  2. Extensive sinonasal polyps that may interfere with the treatment procedure.
  3. Previous sinonasal surgery.
  4. Acute exacerbation of sinusitis in the frontal or sphenoid sinuses.
  5. Sinonasal osteoneogenesis.
  6. Cystic fibrosis.
  7. Sinonasal tumors or obstructive lesions.
  8. Presence of features consistent with sinus fungal disease on CT or physical examination.
  9. History of facial trauma that distorted the sinus anatomy.
  10. Ciliary dysfunction.
  11. History of insulin dependent diabetes.
  12. Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio (INR) is below 1.5.
  13. Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure.
  14. Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure.
  15. Pregnancy.
  16. Psychiatric disease.
  17. Currently participating in other drug or device studies.
  18. Investigator's opinion that the subject should not be in the study such as any conditions that could compromise the wellbeing of the patient or integrity of the study or prevent the patient from meeting or performing study requirements.
  19. Patient is not capable of following the study schedule for any reason.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02931604
Other Study ID Numbers  ICMJE SNS001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party SinuSafe Medical LTD
Study Sponsor  ICMJE SinuSafe Medical LTD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Itzhak Braverman, Professor Hillel Yaffe Medical Center
PRS Account SinuSafe Medical LTD
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP