This study consists of two parts evaluating the efficacy and safety of a fully degradable sinus drug-eluting stent in patients with eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP).
Part A assesses the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery (FESS).
Part B evaluates the stent in patients with early postoperative recurrence of ECRSwNP.
The study aims to answer the following key questions:
Does the use of the stent reduce the recurrence of nasal polyps?
Can the stent reduce the need for oral corticosteroids?
The fully degradable sinus drug-eluting stent is compared with intranasal corticosteroids (Part A) and oral corticosteroids (Part B) to determine whether it offers therapeutic benefit in the management of ECRSwNP.
Participant Procedures:
Part A: Participants will either receive the fully degradable sinus stent or daily intranasal corticosteroids for 6 months. Follow-up visits will occur at Week 2, Week 4, Week 8, Week 12, and Month 6 to record symptoms and adverse events.
Part B: Participants will either receive the fully degradable sinus stent or oral corticosteroids (based on disease progression) for 6 months. Follow-up visits will be conducted at Week 2, Week 4, Week 8, Week 12, and Month 6 for symptom assessment and documentation of adverse events.