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

Chronic Sinusitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06020690
Study type Interventional
Source Enlight Medical Technologies (Shanghai) Co., Ltd
Contact Hu
Phone 08615221991087
Email echo_hu@enlight-medical.com
Status Recruiting
Phase N/A
Start date August 25, 2023
Completion date September 9, 2025
View Details
See also
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