NCT06669130

Xiangtong TM Full Degradation Sinus Drug Stent System Prospective, Open, Single-center, Randomized Controlled Clinical Trial

Efficacy and Safety of Xiangtong TM Full Degradation Sinus Drug Stent System

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Rhinosinusitis (CRS)

Interventions

Type	Name	Description
DEVICE	Xiangtong TM full degradation sinus drug stent system	use Xiangtong TM full degradation sinus drug stent system to deliver drugs into sinus
DEVICE	nasopore	use nasopore to protect the post-operative sinus

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-10-01
• Completion: 2027-10-01
• First posted: 2024-11-01
• Last updated: 2024-11-01