Study Designed to Clinically Evaluate Sinus Wash Device Prototypes

Not Applicable

• Conditions: Sinusitis; Maxillary Sinusitis
• Interventions: Device: SinuSafe Medical Device for Maxillary Sinus

• Registration Number: NCT02931604
• Lead Sponsor: SinuSafe Medical LTD

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 available

Study Timeline

• Study First Submitted: 2016-09-13
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-10
• Last Update Submitted: 2016-10-10
• Study First Posted: 2016-10-13
• Last Update Posted: 2016-10-13
• Study Start: 2017-01
• Primary Completion: 2019-11
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sinus irrigation	SinuSafe Medical Device for Maxillary Sinus	Sinus irrigation intervention

Primary Outcome Measures

Name	Time	Method
Adverse events	Within day 1	Presence of adverse events

Secondary Outcome Measures

Name	Time	Method
Mucosal damage visual inspection	Within 1 hour	Visual inspection of sinus mucosa with the endoscope looking for mucosal damage.
Syringe visual inspection	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	Within 1 hour	Pain during procedure with the VAS pain scale
Usability & Tolerability Questionnaire	Within 1 hour	Usability \& Tolerability Questionnaire
Mucus leftovers visual inspection	Within 1 hour	Visual inspection of sinus mucosa with the endoscope looking for mucus leftovers
Mucus aspiration into the syringe	Within 1 hour	Mucus aspiration into the syringe (yes/ no and time)
Pain relief	Within 1 hour	Pain relief in the post-treatment VAS pain scale
Time measurements of cannula insertion.	Within 1 hour	Time measurements of cannula insertion
Time measurements of irrigation and aspiration	Within 1 hour	Time measurements of irrigation and aspiration
SNOT 20 questionnaire	Within 1 hour	SNOT 20 questionnaire (Hebrew version) to evaluate the patient's severity level before the treatment