Observational Study on the Safety and Performance of PROPEL Corticosteroid-Eluting Sinus Implants in Japanese Adults with Chronic Rhinosinusitis

What this Trial Is About

Researchers are collecting data on the PROPEL family of corticosteroid-eluting sinus implants used in Japanese patients with chronic rhinosinusitis CRS. The study aims to confirm the clinical safety and performance of these implants when used according to instructions for use IFUs and standard care practices in Japan. This observational study focuses on patients undergoing treatment including functional endoscopic sinus surgery FESS. Participants receive standard care treatment for CRS, including FESS, followed by the placement of 2 to 4 PROPEL corticosteroid-eluting implants in the ethmoid or frontal sinuses according to device guidelines. The study observes the use of these implants in routine clinical practice without introducing additional experimental treatments or interventions. During the study, researchers will track changes in the Sino-Nasal Outcome Test-22 SNOT-22 total score from baseline to three months after treatment to assess symptom improvements. Participants are monitored for safety and effectiveness outcomes through six months, with follow-up visits to collect clinical data. The study duration and procedures align with standard care protocols and implant use instructions.

Propel Drug-Eluting Sinus Implant Family IBUKI Cohort