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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Sinusitis Maxillary Sinusitis Device: SinuSafe Medical Device for Maxillary Sinus Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sinus irrigation
Sinus irrigation intervention
 Device: SinuSafe Medical Device for Maxillary Sinus
Sinus lavage via the natural sinus ostium, without ostial dilation.


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


Secondary Outcome Measures :
  1. Mucosal damage visual inspection [ Time Frame: Within 1 hour ]
    Visual inspection of sinus mucosa with the endoscope looking for mucosal damage.

  2. 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.

  3. Pain during procedure [ Time Frame: Within 1 hour ]
    Pain during procedure with the VAS pain scale

  4. Usability & Tolerability Questionnaire [ Time Frame: Within 1 hour ]
    Usability & Tolerability Questionnaire

  5. Mucus leftovers visual inspection [ Time Frame: Within 1 hour ]
    Visual inspection of sinus mucosa with the endoscope looking for mucus leftovers

  6. Mucus aspiration into the syringe [ Time Frame: Within 1 hour ]
    Mucus aspiration into the syringe (yes/ no and time)

  7. Pain relief [ Time Frame: Within 1 hour ]
    Pain relief in the post-treatment VAS pain scale

  8. Time measurements of cannula insertion. [ Time Frame: Within 1 hour ]
    Time measurements of cannula insertion

  9. Time measurements of irrigation and aspiration [ Time Frame: Within 1 hour ]
    Time measurements of irrigation and aspiration

  10. SNOT 20 questionnaire [ Time Frame: Within 1 hour ]
    SNOT 20 questionnaire (Hebrew version) to evaluate the patient's severity level before the treatment


Eligibility Criteria
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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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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Information from the National Library of Medicine

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


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

Sponsors and Collaborators
SinuSafe Medical LTD
Investigators
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Principal Investigator: Itzhak Braverman, Professor Hillel Yaffe Medical Center
More Information
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Responsible Party: SinuSafe Medical LTD
ClinicalTrials.gov Identifier: NCT02931604    
Other Study ID Numbers: SNS001
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Keywords provided by SinuSafe Medical LTD:
sinus wash
sinus lavage
Sinusitis
Additional relevant MeSH terms:
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Sinusitis
Maxillary Sinusitis
Paranasal Sinus Diseases
Nose Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases