Steroid-eluting Sinus Stent for Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms

Chronic Sinusitis Clinical Trial

Official title: Study on the Efficacy of in Office Steroid-eluting Sinus Stent Implantation in Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms

Status Recruiting

Clinical Trial Summary

Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms

Clinical Trial Description

Stent-001 is a randomized (1:1), sham-controlled, parallel group, single-blind, non-inferiority, multicenter study in 96 chronic rhinosinusitis patients who had prior endoscopic sinus surgery and presented with uncontrolled postoperative symptoms. The objective was to evaluate the safety and clinical efficacy of sinus stents relative to systemic glucocorticoids. The steroid-eluting sinus stent consist of a bioabsorbable self-expanding sinus implant coated with 625 mcg of mometasone furoate (MF) and a single-use delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The coating on the sinus stent implant provides controlled release of MF to the sinus mucosa over 30 days. ;

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

• NCT number: NCT06198894
• Study type: Interventional
• Source: Huazhong University of Science and Technology
• Contact: Zheng Liu
• Phone: 86 027 83663807
• Email: zhengliuent@hotmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Completion date: April 10, 2026