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Name: 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
Creator: Tang-Du Hospital
Published: 2026-03-27
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07498374 for Eosinophilic Chronic Rhinosinusitis With Nasal Polyps is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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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 192 Randomized

Recruiting

Clinical Trial NCT07498374 is an interventional study for Eosinophilic Chronic Rhinosinusitis With Nasal Polyps that is recruiting. It started on 21 January 2026 with plans to enroll 192 participants. Led by Tang-Du Hospital, it is expected to complete by 31 December 2028. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.

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 stud...

Official Title

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

Conditions

Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Other Study IDs

K202601-20

NCT ID Number

NCT07498374

Start Date (Actual)

2026-01-21

Last Update Posted

2026-03-27

Completion Date (Estimated)

2028-12-31

Enrollment (Estimated)

192

Study Type

Interventional

PHASE

N/A

Status

Recruiting

Keywords

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

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm

Intervention/Treatment

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

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.

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.

Active Comparatorthe stent in patients with early postoperative recurrence of ECRSwNP

the fully degradable sinus stent

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A:Lund-Kennedy Endoscopic Score and Change from Baseline	Lund-Kennedy endoscopic score (assessing polyps, edema, discharge, scarring, and crusting) at each visit and its change from the baseline (post-operative) score.	Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part A:SNOT-22 Score and Change from Baseline	Sino-Nasal Outcome Test-22 (SNOT-22) score (a patient-reported outcome measure of symptom severity and quality of life impact) at each visit and its change from the baseline score.	Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part A:Time to and Proportion of Complete Mucosal Re-epithelialization	The time to first observed complete re-epithelialization of the nasal mucosa post-surgery, and the proportion of patients achieving it during the study period.	From treatment initiation up to 6 months.
Part A:Time to First Requirement and Cumulative Duration of Systemic Corticosteroid Use	The time from treatment initiation to the first requirement of systemic corticosteroids for symptom control, and the total cumulative duration of systemic corticosteroid use during the 6-month period.	From treatment initiation up to 6 months.
Part A:Proportion of Patients Requiring or Meeting Criteria for Revision Surgery	The proportion of patients who undergo revision surgery or meet the criteria for revision surgery (defined as an endoscopic Nasal Polyp Score ≥ 2 in any unilateral sinus) at each visit.	Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part B:SNOT-22 Score and Change from Baseline	Sino-Nasal Outcome Test-22 (SNOT-22) score at each visit and its change from the baseline score.	Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.
Part B:Time to and Proportion of Complete Mucosal Re-epithelialization	The time to first observed complete re-epithelialization of the nasal mucosa following treatment for early recurrence, and the proportion of patients achieving it.	From treatment initiation up to 6 months.
Part B:Cumulative Dose of Systemic Corticosteroids	The total cumulative dose of systemic corticosteroids used for symptom control during the 6-month treatment period in each group.	From treatment initiation up to 6 months.
Part B: Proportion of Patients Requiring or Meeting Criteria for Revision Surgery	The proportion of patients who undergo revision surgery or meet the criteria for revision surgery (defined as an endoscopic Nasal Polyp Score ≥ 2 in any unilateral sinus) at each visit.	Assessed at Week 2, Week 4, Week 8, Week 12, and Month 6.

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

Part A

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.

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.
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.

Tang-Du Hospital

Study Responsible Party

Tangdu Hospital, Principal Investigator, Director of the Department of Otorhinolaryngology-Head and Neck Surgery, Tangdu Hospital, Tang-Du Hospital

Study Central Contact

Contact: Bian Ka, +86 138 9198 2915, [email protected]

1 Study Locations in 1 Countries

China

Shaanxi

Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi, China., Xi'an, Shaanxi, 710038, China

Tangdu Hospital, Air Force Medical University, Xi'an, Shaanxi bianka, Contact, +86 138 9198 2915, [email protected]

Recruiting