Actively Recruiting
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
Led by Tang-Du Hospital · Updated on 2026-03-27
192
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP)
- Eosinophilic subtype confirmed by pathology with eosinophils >27% of total inflammatory cells or >55 eosinophils per high-power field on staining
- Scheduled for Functional Endoscopic Sinus Surgery (FESS) due to inadequate response to standard therapy for over 3 months, with bilateral nasal polyp scores meeting specific criteria and at least 2 nasal symptoms before screening (Part A)
- Early recurrence state more than 3 months post-FESS with no polyps and specific edema and discharge scores (Part B)
- Voluntary participation with informed consent and ability to complete questionnaires and follow-up visits
You will not qualify if you...
- Previous nasal surgery within 6 months that altered lateral wall structure and prevents polyp assessment
- Allergy to corticosteroids or any component of the sinus drug-eluting stent
- Severe systemic diseases contraindicating surgery
- Other significant nasal diseases such as sinonasal tumor or fungal sinusitis
- Uncontrolled systemic diseases including severe cardiac, liver, kidney dysfunction, or diabetes
- Recent use of steroids, immunosuppressants, biologics, or leukotriene antagonists within specified washout periods
- Recent acute sinusitis episode
- Physical obstruction blocking access to any ethmoid sinus for stent placement
- History or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract
- Pregnant or lactating women
- Participation in another clinical trial within the past month (Part A)
- Postoperative polyp recurrence with any side nasal polyp score above 0 (Part B)
- Use of oral corticosteroids after last FESS procedure (Part B)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China.
Xi'an, Shaanxi, China, 710038
Actively Recruiting
Research Team
B
Bian Ka
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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