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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnose with CRS based on Chinese guidelines for diagnosis and treatment of chronic rhinosinusitis (2018), who were scheduled to undergo primary or revision bilateral ESS.

• Have evidence of bilateral sinus based on computed tomographic (CT) scan (Lund-Mackay \[L-M\] score of \<=3 on each side).

• Can understand the purpose of this study and will to join and finish all the follow up according to the study. Sign the ICF.

Locations
Other Locations
China
Qilu Hospital of Shandong University
RECRUITING
Jinan
Contact Information
Primary
Hu
echo_hu@enlight-medical.com
08615221991087
Time Frame
Start Date: 2023-08-25
Estimated Completion Date: 2025-09-09
Participants
Target number of participants: 93
Treatments
Experimental: Novabel bioabsorbable steroid-releasing stent
Active_comparator: marketed bioabsorbable steroid-releasing stent
Related Therapeutic Areas
Sponsors
Leads: Enlight Medical Technologies (Shanghai) Co., Ltd

This content was sourced from clinicaltrials.gov