UnknownNot Applicable

Study Designed to Clinically Evaluate Sinus Wash Device Prototypes

50 participantsStarted 2017-01

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female, 18-65 years of age.
✓. Signs and symptoms of acute exacerbation during chronic maxillary sinusitis.
✓. Pain higher than 5 in VAS of 0-10.
✓. Able to understand and provide written informed consent.

Exclusion criteria

✕. 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.
✕. Extensive sinonasal polyps that may interfere with the treatment procedure.
✕. Previous sinonasal surgery.
✕. Acute exacerbation of sinusitis in the frontal or sphenoid sinuses.
✕. Sinonasal osteoneogenesis.
✕. Cystic fibrosis.
✕. Sinonasal tumors or obstructive lesions.
✕. Presence of features consistent with sinus fungal disease on CT or physical examination.

What they're measuring

Adverse events

Timeframe: Within day 1

Trial details

NCT IDNCT02931604

SponsorSinuSafe Medical LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11

Contact for this trial

Avinoam Gemer

972-544-858822 avinoamgemer@gmail.com

View on ClinicalTrials.gov More Sinusitis trials