NCT06198894

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Zheng Liu · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
PROCEDURE	steroid-eluting sinus stent implant	In-office bilateral placement of the steroid-eluting sinus stent in the ethmoid sinuses under local anesthesia
DRUG	Systemic glucocorticoids	Groups were given oral methylprednisolone (32 mg/d on days 1-5; 16 mg/d on days 6-10; and 8 mg/d on days 11-20),
DRUG	saline irrigations	Patients were routinely treated with saline irrigations (250ml) twice daily
DRUG	Placebo	Groups were given systemic glucocorticoid placebo
PROCEDURE	sham procedure	The sham procedure was performed in-office under local anesthesia

Timeline

• Start date: 2024-01-10
• Primary completion: 2026-01-10
• Completion: 2026-04-10
• First posted: 2024-01-10
• Last updated: 2024-01-18

Locations

1 site across 1 country: China