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Steroid-Eluting Stent Implant for the Treatment of Radiation-Related Sinusitis

NCT05757479 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2023-03-07

No results posted yet for this study

Summary

Sinusitis is one of the most common sequelae after radiotherapy among nasopharyngeal carcinoma patients. While local steroids have been shown to be effective in the management of patients with chronic rhinosinusitis, their role in treating radiation-related sinusitis is ambiguous. Poor adherence to nasal steroid spray often contributes to the failure of symptom relief. The aim of this study is to determine if steroids stents implantation into the sinuses could improve patient outcomes in radiation-related sinusitis.

Conditions

  • Radiation-Induced Mucositis

Interventions

PROCEDURE

Steroid-eluting stent implantation

The sinus cavity with inflammation receives one bioabsorbable steroid-eluting sinus stent.

DRUG

Steroid nasal spray

1 spray into each nostril once a day.

PROCEDURE

nasal saline rinses

The saltwater runs through nasal passages and drains out of the nostril.

Sponsors & Collaborators

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Fifth Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming-Yuan Chen, MD, PhD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-02-11
Primary Completion
2023-12-31
Completion
2024-07-01

Countries

  • China

Study Locations

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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 NCT05757479 on ClinicalTrials.gov