NCT06020690

A Clinical Study to Evaluate the Safety and Effectiveness of Novabel Bioabsorbable Steroid-releasing Stent for the Chronic Sinusitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-08-25
• Primary completion: 2024-09-09
• Completion: 2025-09-09
• First posted: 2023-09-01
• Last updated: 2023-10-26

Locations

1 site across 1 country: China