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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:
Researchers will compare test device and marketed device to see if the safety and effectiveness between these two devices are non-inferior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novabel bioabsorbable steroid-releasing stent | Experimental |
| |
| marketed bioabsorbable steroid-releasing stent | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bioabsorbable steroid-releasing stent | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| non reintervention rate | The need for postoperative interventions, medical and surgical, as determined based on review of video endoscopic findings by an independent blinded surgeon. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lund-Kennedy score | Lund-Kennedy endoscopic scoring system based on polyps, oedema, discharge, scarring and crusting. from 0-2 is None/absent; mild; severe. | 30 days, 90 days, 180 days and 1 year |
| Lund-Mackay score |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event rate | immediately after the procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hu | Contact | 08615221991087 | echo_hu@enlight-medical.com |
| Name | Affiliation | Role |
|---|---|---|
| Li | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | China |
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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.
| 90 days |
| VAS score | A 100mm VAS, ranging from 0 (no pain) to 100 (very severe pain), is used to measure pain intensity throughout the previous 24h. | 30 days, 90 days, 180 days and 1 year |
| sinus panty rate | as determined based on review of video endoscopic findings by an independent blinded surgeon | 30 days, 90 days, 180 days and 1 year |
| implantation successful rate | immediately after the procedure |