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.
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