Study Designed to Clinically Evaluate Sinus Wash Device Prototypes

SinuSafe Medical

Status: Unknown

Conditions: Maxillary Sinusitis; Sinusitis

Treatments: Device: SinuSafe Medical Device for Maxillary Sinus

Study type: Interventional

Funder types: Industry

Identifiers

NCT02931604

SNS001

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Sinus irrigation

Experimental group

Description:

Sinus irrigation intervention

Treatment:

Device: SinuSafe Medical Device for Maxillary Sinus