Status:
UNKNOWN
A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis
Lead Sponsor:
Enlight Medical Technologies (Shanghai) Co., Ltd
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn about the safety and effectiveness of Novabel bioabsorbable steroid-releasing stent in chronic sinusitis. The main questions it aims to answer are: * The s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 9 2025
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT06020690
Start Date
August 25 2023
End Date
September 9 2025
Last Update
October 26 2023
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, China