Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation

Chronic Sinusitis, Ethmoidal Clinical Trial

Official title:

Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05863468
• Other study ID #: 461010P
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: December 21, 2023

Study information

• Verified date: January 2023
• Source: STS Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4
• Est. completion date: December 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male/female, 18 year or older

• Diagnosis of chronic rhinosinusitis defined as symptomatic inflammation of the sinuses of at least 12 consecutive weeks duration despite medical management

• = 3 months post primary FESS

• Symptoms of chronic rhinosinusitis defined as = 10 score on SNOT-22

• Middle turbinate lateralization defined as ? 2 score on MT lateralization scale

Exclusion Criteria:

• Polyp grade ? 4 bilaterally on Lildholdt's scale (1-3)

• Sinonasal tumors

• Known allergy to nickel

• Known polyurethane induced dermatitis

• History of immune deficiency

• Cystic fibrosis

• Pregnant or lactating female

• Acute sinus inflammation

• Coagulation disorders

Related Conditions & MeSH terms

• Chronic Sinusitis, Ethmoidal
• Ethmoid Sinusitis
• Sinusitis

Intervention

Device:
• ArchSinus implantation
Unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
STS Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinus airflow and particle deposition rate	The primary objective of this study aims to compare the sinonasal airflow rate and particle deposition rate at Baseline and 12 weeks after the ArchSinus stent implantation, based on CFD analysis.	12 weeks
Secondary	Symptomatic improvement	The secondary objective of this study is to analyze correlation between an increased sinus airflow and symptomatic improvement, assessed using SNOT-22 and NOSE Questioners, at baseline and at 1, 6 and 12 weeks after the ArchSinus stent removal.	12 weeks