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RECRUITING

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

Sponsor: Tang-Du Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2026-01-21

Completion Date

2028-12-31

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Interventions

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.

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.

Locations (1)

Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China.

Xi'an, Shaanxi, China