A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis
Study Details
Study Description
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:
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The safety of this device for the chronic sinusitis
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The effectiveness of this device for the chronic sinusitis Participants will be implanted bioabsorbable steroid-releasing stents after FESS surgery. Participants will be asked to be back to the clinic for follow-up 14 days, 30 days, 90 days, 180 days and 360 days after procedure.
Researchers will compare test device and marketed device to see if the safety and effectiveness between these two devices are non-inferior.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Novabel bioabsorbable steroid-releasing stent
|
Device: bioabsorbable steroid-releasing stent
The patient after functional endoscopic sinus surgery to treat their chronic sinusitis, the experimental device or active comparator device will be implanted to the sinus to prevent re-intervention (surgery or medicine).
Other Names:
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| Active Comparator: marketed bioabsorbable steroid-releasing stent
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Device: bioabsorbable steroid-releasing stent
The patient after functional endoscopic sinus surgery to treat their chronic sinusitis, the experimental device or active comparator device will be implanted to the sinus to prevent re-intervention (surgery or medicine).
Other Names:
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Outcome Measures
Primary Outcome Measures
- non reintervention rate [30 days]
The need for postoperative interventions, medical and surgical, as determined based on review of video endoscopic findings by an independent blinded surgeon.
Secondary Outcome Measures
- Lund-Kennedy score [30 days, 90 days, 180 days and 1 year]
Lund-Kennedy endoscopic scoring system based on polyps, oedema, discharge, scarring and crusting. from 0-2 is None/absent; mild; severe.
- Lund-Mackay score [90 days]
Each side of sinus is graded separately: 0 (no abnormality); 1 (partial opacification); 2 (complete opacification). If there is no frontal sinus (aplasia), the score is 0. Scores were calculated based on the results of a paranasal sinus CT scan 1-3 mm axial slice thickness with coronal and sagittal reconstruction. Result: score 0-24.
- VAS score [30 days, 90 days, 180 days and 1 year]
A 100mm VAS, ranging from 0 (no pain) to 100 (very severe pain), is used to measure pain intensity throughout the previous 24h.
- sinus panty rate [30 days, 90 days, 180 days and 1 year]
as determined based on review of video endoscopic findings by an independent blinded surgeon
- implantation successful rate [immediately after the procedure]
Other Outcome Measures
- adverse event rate [immediately after the procedure]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Have evidence of bilateral sinus based on computed tomographic (CT) scan (Lund-Mackay [L-M] score of <=3 on each side).
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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:
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Know history of allergy or intolerance to corticosteroids or mometasone furoate.
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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).
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Clinical evidence of cystic fibrosis, severe polyposis or sinonasal tumors.
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Clinical evidence of acute bacterial sinusitis or suspicion of invasive fungal sinusitis.
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Glaucoma, ocular hypertension, posterior subcapsular cataracts.
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Known history of immune deficiency or concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease.
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Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 360 day follow-up period.
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Current ESS including frontal sinus surgery is aborted for any reason.
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Pregnant or lactating female
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Investigator determination that the potential study subject is unable to comply with study procedures and/or follow-up, or provided informed consent.
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Currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of the clinical study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu Hospital of Shandong University | Jinan | China |
Sponsors and Collaborators
- Enlight Medical Technologies (Shanghai) Co., Ltd
Investigators
- Principal Investigator: Li, Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YM-2023-003