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

Recruiting N/A Interventional Study
Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
192 (estimated)
Sponsor
Tang-Du Hospital · Other
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About This Trial
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 o…
Trial Locations
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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…
Contacts

Bian Ka

+86 138 9198 2915

kabia@fmmu.edu.cn

CONTACT