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

NCT06198894 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-01-18

No results posted yet for this study

Summary

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

Conditions

  • Chronic Sinusitis

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

Sponsors & Collaborators

  • Zheng Liu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2026-01-10
Completion
2026-04-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06198894 on ClinicalTrials.gov