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

NCT07498374 | Recruiting

• 1 other identifier: K202601-20
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Keywords

eosinophilic chronic rhinosinusitis with nasal polyps; fully degradable sinus drug-eluting stent

Outcome Measures

Primary Outcomes (3)

• Part A: Median Time to Early Polyp/Edema Recurrence Within 6 Months

  The median time to the development of early polyp recurrence and/or edema (defined as polypoid change or a Lund-Kennedy edema score ≥ 1) within 6 months post-treatment.

  From treatment initiation up to 6 months.

• Part A: Incidence Rate of Early Polyp/Edema Recurrence at Each Visit

  The proportion of patients presenting with early polyp recurrence and/or edema (defined as polypoid change or a Lund-Kennedy edema score ≥ 1) at each scheduled visit (Week 2, 4, 8, 12, and Month 6).

  Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.

• Part B:Lund-Kennedy Endoscopic Score and Change from Baseline

  Lund-Kennedy endoscopic score at each scheduled visit and its change from the baseline score (at the time of early recurrence diagnosis/treatment initiation).

  Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.

Secondary Outcomes (9)

• Part A:Lund-Kennedy Endoscopic Score and Change from Baseline

  Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.

• Part A:SNOT-22 Score and Change from Baseline

  Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.

• Part A:Time to and Proportion of Complete Mucosal Re-epithelialization

  From treatment initiation up to 6 months.

• Part A:Time to First Requirement and Cumulative Duration of Systemic Corticosteroid Use

  From treatment initiation up to 6 months.

• Part A:Proportion of Patients Requiring or Meeting Criteria for Revision Surgery

  Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.

Study Arms (2)

the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery

ACTIVE COMPARATOR

Device: the fully degradable sinus stent; Drug: intranasal corticosteroids

the stent in patients with early postoperative recurrence of ECRSwNP

ACTIVE COMPARATOR

Device: the fully degradable sinus stent; Drug: oral corticosteroids

Interventions

the fully degradable sinus stent DEVICE

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.

the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery; the stent in patients with early postoperative recurrence of ECRSwNP

intranasal corticosteroids DRUG

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.

the efficacy and safety of the stent when used immediately after functional endoscopic sinus surgery

oral corticosteroids DRUG

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.

the stent in patients with early postoperative recurrence of ECRSwNP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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).

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

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

Xi'an, Shaanxi, 710038, China

RECRUITING

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Bian Ka

CONTACT

+86 138 9198 2915; kabia@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Otorhinolaryngology-Head and Neck Surgery, Tangdu Hospital

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: March 27, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (1)