Steroid-Eluting Stent Implant for the Treatment of Radiation-Related Sinusitis
NCT ID: NCT05757479
Last Updated: 2023-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
168 participants
INTERVENTIONAL
2023-02-11
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Steroid-eluting stent implant
Subjects randomized to the experimental group will receive steroid-eluting stent implantation in the affected sinus and saline rinses.
Steroid-eluting stent implantation
The sinus cavity with inflammation receives one bioabsorbable steroid-eluting sinus stent.
nasal saline rinses
The saltwater runs through nasal passages and drains out of the nostril.
Nasal steroid spray
Subjects randomized to the comparator group will receive nasal steroid spray and saline rinses.
Steroid nasal spray
1 spray into each nostril once a day.
nasal saline rinses
The saltwater runs through nasal passages and drains out of the nostril.
Interventions
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Steroid-eluting stent implantation
The sinus cavity with inflammation receives one bioabsorbable steroid-eluting sinus stent.
Steroid nasal spray
1 spray into each nostril once a day.
nasal saline rinses
The saltwater runs through nasal passages and drains out of the nostril.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* finished radical radiotherapy (≥66Gy) for at least 3 months
* tumor complete response
* received appropriate medical treatment for sinusitis during or after radiotherapy
* confirmed sinusitis according to European Position Paper on Rhinosinusitis and Nasal Polyps 2020
* SNOT-22 ≥ 20 and MRI Lund-Mackay score \> 8
* 18-70 years old
Exclusion Criteria
* Karnofsky score ≤ 70
* life-threatening medical conditions
* tumour residue or recurrence
* acute bacterial sinusitis or acute fungal sinusitis
* cystic fibrosis or primary ciliary dyskinesia
* dependence on prolonged corticosteroid therapy for comorbid conditions
* history of allergy to topical steroids
* pregnant or breastfeeding
18 Years
70 Years
ALL
No
Sponsors
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Zhongshan People's Hospital, Guangdong, China
OTHER
Fifth Affiliated Hospital of Guangzhou Medical University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Ming-Yuan Chen
professor & chief physician
Principal Investigators
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Ming-Yuan Chen, MD, PhD
Role: STUDY_CHAIR
Sun Yat-sen University
Locations
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Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SYSUCC-CMY-2022-sinusitis
Identifier Type: -
Identifier Source: org_study_id
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