Fully resorbable drug‑eluting sinus stent for eosinophilic nasal polyps after surgery

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

This trial tries a fully resorbable drug-releasing sinus stent in adults with eosinophilic chronic rhinosinusitis with nasal polyps after surgery or with early polyp return to see if it lowers polyp recurrence and reduces the need for oral steroids.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 192 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tang-Du Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07498374 on ClinicalTrials.gov

What this trial studies

This randomized, controlled study has two parts testing a fully degradable, drug‑eluting sinus stent in patients with eosinophilic chronic rhinosinusitis with nasal polyps. Part A compares placement of the stent immediately after functional endoscopic sinus surgery (FESS) to standard daily intranasal corticosteroids for six months. Part B enrolls patients with early postoperative recurrence and compares the stent to oral corticosteroids. Outcomes include polyp recurrence and the need for systemic steroids, with scheduled follow-up visits to monitor safety and efficacy.

Who should consider this trial

Good fit: Adults 18–65 with eosinophilic CRSwNP confirmed by pathology who are scheduled for FESS or who have early postoperative polyp recurrence are ideal candidates.

Not a fit: Patients without the eosinophilic subtype, those with recent surgery that alters nasal anatomy, or those unable to undergo the surgical placement procedure are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the stent could reduce polyp recurrence and lower reliance on oral corticosteroids, improving symptom control and reducing steroid exposure.

How similar studies have performed: Bioabsorbable steroid‑eluting sinus stents have previously shown benefit in reducing postoperative inflammation and maintaining sinus patency, but data specific to fully degradable stents in eosinophilic CRSwNP are limited.

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.

Where this trial is running

Xi'an, Shaanxi

• Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China. — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Bian Ka

Conditions Eosinophilic Chronic Rhinosinusitis With Nasal Polyps; eosinophilic chronic rhinosinusitis with nasal polyps; fully degradable sinus drug-eluting stent