Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Sinusitis, Ethmoidal
• Intervention / Treatment: Device: ArchSinus 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.

• Study Type: Interventional
• Enrollment (Anticipated): 4
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ArchSinus implantation; Subjects will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation	Device: ArchSinus implantation; Unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: STS Medical

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2023
• Primary Completion (Anticipated): November 21, 2023
• Study Completion (Anticipated): December 21, 2023

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Ethmoid Sinusitis
• Other Study ID Numbers: 461010P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No