NCT05863468

Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (estimated)
• Sponsor: STS Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, single-arm, interventional case study designed to compare the sinonasal airflow and symptomatic status of four (4) chronic sinusitis patients, before and after the ArchSinus stent implantation.

Detailed description

This is a single-center, single-arm, interventional case study. This case study is designed to compare the sinonasal airflow and symptomatic status of four (4) chronic sinusitis patients who after undergoing primary FESS were seen to have symptomatic lateralization of the middle turbinate and underwent medialization of the middle turbinate accompanied by ArchSinus stent implantation. Patient eligibility will be confirmed based on the endoscopic examination and SNOT-22 score. Patient history will be taken, specifically which if any nasal spacer was used after the primary FESS. 4 chronic sinusitis patients that suffer from middle turbinate lateralization and symptomatic deterioration, 3-6 months after primary FESS, that met the inclusion / exclusion criteria, will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation. The stents will be removed 2-3 weeks after procedure. CT scan will be performed at baseline and 12 weeks after the ArchSinus stent removal, and 3D sinonasal airways reconstruction of the maxillary, ethmoid, sphenoid \& frontal sinuses will be performed. Subsequently, airflow and particle deposition will be simulated in each reconstruction, and airflow rate and particle deposition will be quantified for different sinuses. Symptomatic status will be analyzed at baseline and 1, 6 and 12 weeks after the ArchSinus stent removal using SNOT-22 and NOSE Questioners. Debridement is disallowed during the ArchSinus implantation time period. Nasal decongestions are disallowed prior to CT scan examination.

Conditions

• Chronic Sinusitis, Ethmoidal

Interventions

Type	Name	Description
DEVICE	ArchSinus implantation	Unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation

Timeline

• Start date: 2023-06-15
• Primary completion: 2023-11-21
• Completion: 2023-12-21
• First posted: 2023-05-18
• Last updated: 2023-05-18