Chronic Sinusitis
Conditions
Keywords
bioabsorbable, steroid-releasing stent
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 safety of this device for the chronic sinusitis * 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.
Interventions
DEVICEbioabsorbable 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).
Sponsors
Enlight Medical Technologies (Shanghai) Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 | — |
| 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. |
Other
| Measure | Time frame |
|---|---|
| adverse event rate | immediately after the procedure |
Countries
China
Contacts
Primary ContactHu
Outcome results
None listed