A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis

Launched by ENLIGHT MEDICAL TECHNOLOGIES (SHANGHAI) CO., LTD · Aug 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new medical device called the Novabel bioabsorbable steroid-releasing stent, which is designed to help people with chronic sinusitis. Chronic sinusitis is a long-lasting condition that causes inflammation and swelling in the sinuses, leading to symptoms like nasal congestion and facial pain. The study aims to find out if this stent is safe and effective when placed in patients after a specific type of sinus surgery called Functional Endoscopic Sinus Surgery (FESS). Participants will receive the stent and will need to return to the clinic for follow-up visits at 14, 30, 90, 180, and 360 days after their surgery.

To be eligible for this trial, participants should be between 65 and 74 years old, diagnosed with chronic sinusitis according to certain guidelines, and scheduled for either their first or a repeat sinus surgery. They should also have specific findings on a CT scan showing issues in both sides of the sinuses. People with certain allergies, specific medical conditions, or who are pregnant cannot participate. If you join the study, you'll be helping researchers compare this new stent to an already available device to see which one works better for patients.

Gender

ALL

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:
• • 1. Know history of allergy or intolerance to corticosteroids or mometasone furoate.
• • 2. 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).
• • 3. Clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors.
• • 4. Clinical evidence of acute bacterial sinusitis or suspicion of invasive fungal sinusitis.
• • 5. Glaucoma, ocular hypertension, posterior subcapsular cataracts.
• • 6. Known history of immune deficiency or concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease.
• • 7. Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 360 day follow-up period.
• • 8. Current ESS including frontal sinus surgery is aborted for any reason.
• • 9. Pregnant or lactating female
• • 10. Investigator determination that the potential study subject is unable to comply with study procedures and/or follow-up, or provided informed consent.
• • 11. Currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of the clinical study.