Clinical trial NCT02931604: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sinusitis
Maxillary Sinusitis
Keywords: sinus wash
sinus lavage
Sinusitis
Lead sponsor: SinuSafe Medical LTD
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Adverse events
timeFrame: Within day 1
Secondary outcomes:
measure: Mucosal damage visual inspection
timeFrame: Within 1 hour
measure: Syringe visual inspection
timeFrame: Within 1 hour
measure: Pain during procedure
timeFrame: Within 1 hour
measure: Usability & Tolerability Questionnaire
timeFrame: Within 1 hour
measure: Mucus leftovers visual inspection
timeFrame: Within 1 hour
measure: Mucus aspiration into the syringe
timeFrame: Within 1 hour
measure: Pain relief
timeFrame: Within 1 hour
measure: Time measurements of cannula insertion.
timeFrame: Within 1 hour
measure: Time measurements of irrigation and aspiration
timeFrame: Within 1 hour
measure: SNOT 20 questionnaire
timeFrame: Within 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Itzhak Braverman, Professor
role: PRINCIPAL_INVESTIGATOR
References: