Study Designed to Clinically Evaluate Sinus Wash Device Prototypes

• ClinicalTrials.gov Identifier: NCT02931604
• Recruitment Status: Unknown
• First Posted: October 13, 2016
• Last Update Posted: October 13, 2016
• Sponsor: SinuSafe Medical LTD
• Information provided by (Responsible Party): SinuSafe Medical LTD

Tracking Information

• First Submitted Date: September 13, 2016
• First Posted Date: October 13, 2016
• Last Update Posted Date: October 13, 2016
• Study Start Date: January 2017
• Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 10, 2016)

Adverse events [ Time Frame: Within day 1 ]

Presence of adverse events

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Designed to Clinically Evaluate Sinus Wash Device Prototypes
• 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 Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Sinusitis
• Maxillary Sinusitis

Intervention

Device: SinuSafe Medical Device for Maxillary Sinus

Sinus lavage via the natural sinus ostium, without ostial dilation.

Study Arms

Experimental: Sinus irrigation

Sinus irrigation intervention

Intervention: Device: SinuSafe Medical Device for Maxillary Sinus

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 10, 2016): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2020
• Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02931604
• Other Study ID Numbers: SNS001
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: SinuSafe Medical LTD
• Study Sponsor: SinuSafe Medical LTD
• Collaborators: Not Provided

Investigators

• Principal Investigator: Itzhak Braverman, Professor; Hillel Yaffe Medical Center

• PRS Account: SinuSafe Medical LTD
• Verification Date: October 2016