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Xiangtong® Fully Degradable Sinus Drug Stent System is a high-tech medical device independently developed by Puyi Bio, specially designed for patients with chronic rhinosinusitis (CRS) undergoing endoscopic sinus surgery (ESS).The product is implanted into the target site during and after surgery, which not only supports the separation of the wound and fixes the repaired mucosal flap, but also controls edema, prevents adhesions, maintains smooth drainage, and sustains the target site to fight against inflammation and promotes healing by means of slow-release hormones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xiangtong TM full degradation sinus drug stent system | Experimental |
| |
| nasopore | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiangtong TM full degradation sinus drug stent system | Device | use Xiangtong TM full degradation sinus drug stent system to deliver drugs into sinus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative reintervention rates based on imaging evaluations | 30 days after operation |
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Inclusion Criteria:
Subjects must meet the diagnostic guidelines for chronic rhinosinusitis, have a confirmed diagnosis of bilateral chronic rhinosinusitis, and have a CT scan confirming bilateral Lund-Mackay scores >6 (CT scan within 3 months prior to surgery is valid).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Lei | Contact | 13776620807 | chenglei@jsph.org.cn |
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| nasopore | Device | use nasopore to protect the post-operative sinus |
|