Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06198894
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steroid-eluting Sinus Stent for Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms
Sponsor:
Zheng Liu
Organization:
Study Overview
Official Title:
Study on the Efficacy of in Office Steroid-eluting Sinus Stent Implantation in Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: