Study Designed to Clinically Evaluate Sinus Wash Device Prototypes

Sinusitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02931604
• Other study ID #: SNS001
• Status: Not yet recruiting
• Phase: N/A
• First received: September 13, 2016
• Last updated: October 10, 2016
• Start date: January 2017
• Est. completion date: January 2020

Study information

• Verified date: October 2016
• Source: SinuSafe Medical LTD
• Contact: Avinoam Gemer
• Phone: 972-544-858822
• Email: avinoamgemer[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Clinical Trials Department - Devices & Advanced Therapies Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Maxillary Sinusitis
• Sinusitis

Intervention

Device:
• SinuSafe Medical Device for Maxillary Sinus
Sinus lavage via the natural sinus ostium, without ostial dilation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SinuSafe Medical LTD

Outcome

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