NCT07498374

Efficacy and Safety of Fully Resorbable Sinus Drug-eluting Stents in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps After Surgery: A Prospective, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
DEVICE	the fully degradable sinus stent	The intervention is a fully degradable sinus drug-eluting stent system. The stent will be implanted into the bilateral targeted sinus cavities of the participants. Part A Cohort: The stent is placed immediately following Functional Endoscopic Sinus Surgery (FESS). Part B Cohort: The stent is placed when participants are assessed to be in a state of early postoperative recurrence.
DRUG	intranasal corticosteroids	This is the intervention for the drug comparator group in Part A. Participants will administer a prescribed dose of intranasal corticosteroid spray daily via bilateral nasal application according to the protocol.
DRUG	oral corticosteroids	This is the intervention for the drug comparator group in Part B. Participants will receive a prescribed course of oral corticosteroids as needed based on clinical assessment and upon signs of early postoperative recurrence, in accordance with the study protocol.

Timeline

• Start date: 2026-01-21
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China