Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Study Designed to Clinically Evaluate Sinus Wash Device Prototypes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by SinuSafe Medical LTD
Sponsor:
Information provided by (Responsible Party):
SinuSafe Medical LTD
ClinicalTrials.gov Identifier:
NCT02931604
First received: September 13, 2016
Last updated: October 10, 2016
Last verified: October 2016
  Purpose
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

Condition Intervention
Sinusitis
Maxillary Sinusitis
Device: SinuSafe Medical Device for Maxillary Sinus

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by SinuSafe Medical LTD:

Primary Outcome Measures:
  • Adverse events [ Time Frame: Within day 1 ]
    Presence of adverse events


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: January 2017
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sinus irrigation
Sinus irrigation intervention
Device: SinuSafe Medical Device for Maxillary Sinus
Sinus lavage via the natural sinus ostium, without ostial dilation.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02931604

Contacts
Contact: Avinoam Gemer 972-544-858822 avinoamgemer@gmail.com

Sponsors and Collaborators
SinuSafe Medical LTD
Investigators
Principal Investigator: Itzhak Braverman, Professor Hillel Yaffe Medical Center
  More Information

Responsible Party: SinuSafe Medical LTD
ClinicalTrials.gov Identifier: NCT02931604     History of Changes
Other Study ID Numbers: SNS001
Study First Received: September 13, 2016
Last Updated: October 10, 2016

Keywords provided by SinuSafe Medical LTD:
sinus wash
sinus lavage
Sinusitis

Additional relevant MeSH terms:
Sinusitis
Maxillary Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2017