Study Designed to Clinically Evaluate Sinus Wash Device Prototypes

Pilot Study Designed to Clinically Evaluate Sinus Wash Device Prototypes in Patients With Sinusitis During Endoscopic Sinus Surgery (ESS) and in the Hospital Outpatient

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

Study Overview

• Status: Unknown
• Conditions: Sinusitis; Maxillary Sinusitis
• Intervention / Treatment: Device: SinuSafe Medical Device for Maxillary Sinus

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Avinoam Gemer; Phone Number: 972-544-858822; Email: avinoamgemer@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Presence of adverse events	Within day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SinuSafe Medical LTD
• Investigators: Principal Investigator: Itzhak Braverman, Professor, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 10, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Sinusitis; sinus wash; sinus lavage
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Maxillary Sinusitis
• Other Study ID Numbers: SNS001