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
Recruiting now · Not applicable
Conditions studied: Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
In brief
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.
Key facts
- Study ID
- NCT07498374
- Run by
- Tang-Du Hospital
- People needed
- 192
- Starts
- 2026-01-21
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Inclusion Criteria:
- 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 Criteria:
- 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.
Where it is running
- Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China. — Xi'an, Shaanxi, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.