Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation

NCT ID: NCT05863468

Last Updated: 2023-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2023-12-21

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ArchSinus implantation

Subjects will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation

Group Type: EXPERIMENTAL

ArchSinus implantation

Intervention Type: DEVICE

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

Interventions

ArchSinus implantation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

STS Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

461010P

Identifier Type: -

Identifier Source: org_study_id