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RECRUITING
NCT06198894
NA

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

Sponsor: Zheng Liu

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2024-01-10

Completion Date

2026-04-10

Last Updated

2024-01-18

Healthy Volunteers

No

Interventions

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

Locations (1)

Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China