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
| NCT ID | NCT07498374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tang-Du Hospital |
| Condition | Eosinophilic Chronic Rhinosinusitis With Nasal Polyps |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2026-01-21 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2026-01-21 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Part A Inclusion Criteria: 1. Age 18-65 years. 2. Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP). 3. 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). 4. 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. 5. Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits. Exclusion Criteria: 1. Previous nasal surgery within 6 months before screening that altered lateral wall structure and precludes polyp assessment. 2. Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent. 3. Severe systemic disease contraindicating surgery. 4. Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis). 5. Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes). 6. 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. 7. Recent acute sinusitis episode. 8. Physical obstruction preventing access to any ethmoid sinus for stent delivery. 9. Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract. 10. Pregnant or lactating women. 11. Participation in another clinical trial within the past 1 month. Part B Inclusion Criteria: 1. Age 18-65 years. 2. Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP). 3. 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). 4. 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. 5. Voluntarily participates, provides informed consent, and is able to complete questionnaires and follow-up visits. Exclusion Criteria: 1. Postoperative polyp recurrence in ECRSwNP patients, with any side NPS \> 0. 2. Use of oral corticosteroids after the last FESS procedure. 3. Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent. 4. Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis). 5. Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes). 6. 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. 7. Recent acute sinusitis episode. 8. Physical obstruction preventing access to any ethmoid sinus for stent delivery. 9. Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract. 10. Pregnant or lactating women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07498374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Eosinophilic Chronic Rhinosinusitis With Nasal Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07498374 currently recruiting?
Yes, NCT07498374 is actively recruiting participants. Contact the research team at kabia@fmmu.edu.cn for enrollment information.
Where is the NCT07498374 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT07498374 clinical trial?
NCT07498374 is sponsored by Tang-Du Hospital. The trial plans to enroll 192 participants.