A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis
Chronic Sinusitis
About this trial
This is an interventional treatment trial for Chronic Sinusitis focused on measuring bioabsorbable, steroid-releasing stent
Eligibility Criteria
Inclusion Criteria: Diagnose with CRS based on Chinese guidelines for diagnosis and treatment of chronic rhinosinusitis (2018), who were scheduled to undergo primary or revision bilateral ESS. Have evidence of bilateral sinus based on computed tomographic (CT) scan (Lund-Mackay [L-M] score of <=3 on each side). Can understand the purpose of this study and will to join and finish all the follow up according to the study. Sign the ICF. Exclusion Criteria: Know history of allergy or intolerance to corticosteroids or mometasone furoate. The subject has a known allergic reaction or contraindication to the device material and its degradation products (L-polylactic acid, racemic polylactic acid, lactide lactate, lactic acid). Clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors. Clinical evidence of acute bacterial sinusitis or suspicion of invasive fungal sinusitis. Glaucoma, ocular hypertension, posterior subcapsular cataracts. Known history of immune deficiency or concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease. Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 360 day follow-up period. Current ESS including frontal sinus surgery is aborted for any reason. Pregnant or lactating female Investigator determination that the potential study subject is unable to comply with study procedures and/or follow-up, or provided informed consent. Currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of the clinical study.
Sites / Locations
- Qilu Hospital of Shandong University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Novabel bioabsorbable steroid-releasing stent
marketed bioabsorbable steroid-releasing stent