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
Tang-Du Hospital
192 participants
Jan 21, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria11
- Part A
- Age 18-65 years.
- Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
- Eosinophilic subtype confirmed by pathology (eosinophils \>27% of total infiltrating inflammatory cells in polyp tissue, OR absolute count \>55 eosinophils per high-power field (HPF) on H\&E staining).
- Indicated and scheduled for Functional Endoscopic Sinus Surgery (FESS) due to inadequate response to standard medical therapy for \>3 months, with bilateral endoscopic Nasal Polyp Score (NPS) ≥5 (max 8), each side ≥2, and presenting at least 2 of the following symptoms before screening: nasal blockage/congestion, anterior/posterior nasal discharge, facial pain/pressure, or reduced/loss of smell.
- Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.
- Age 18-65 years.
- Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP).
- Eosinophilic subtype confirmed by pathology (eosinophils \>27% of total infiltrating inflammatory cells in polyp tissue, OR absolute count \>55 eosinophils per high-power field (HPF) on H\&E staining).
- Early recurrence state: \>3 months post-FESS with standard therapy, no polyps (NPS=0), Lund-Kennedy (LK) edema score ≥2, and LK discharge score ≥2.
- Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits.
Exclusion Criteria22
- Previous nasal surgery within 6 months before screening that altered lateral wall structure and precludes polyp assessment.
- Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
- Severe systemic disease contraindicating surgery.
- Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
- Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
- Recent use of steroids (30-day washout for parenteral, 14-day for oral, budesonide drops/irrigation, nebulized), immunosuppressants/biologics (within 5 terminal half-lives), or leukotriene antagonists/modulators prior to baseline.
- Recent acute sinusitis episode.
- Physical obstruction preventing access to any ethmoid sinus for stent delivery.
- Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
- Pregnant or lactating women.
- Participation in another clinical trial within the past 1 month.
- Part B
- Postoperative polyp recurrence in ECRSwNP patients, with any side NPS \> 0.
- Use of oral corticosteroids after the last FESS procedure.
- Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
- Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
- Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
- Recent use of steroids (30-day washout for parenteral, 14-day for oral, budesonide drops/irrigation, nebulized), immunosuppressants/biologics (within 5 terminal half-lives), or leukotriene antagonists/modulators prior to baseline.
- Recent acute sinusitis episode.
- Physical obstruction preventing access to any ethmoid sinus for stent delivery.
- Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
- Pregnant or lactating women.
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Interventions
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.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07498374