Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation

NCT05863468 | Unknown

• 1 other identifier: 461010P
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Sinusitis, Ethmoidal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Symptomatic improvement

  12 weeks

Study Arms (1)

ArchSinus implantation

EXPERIMENTAL

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

Device: ArchSinus implantation

Interventions

ArchSinus implantation DEVICE

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

ArchSinus implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• STS Medical: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4 chronic sinusitis patients will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation. Baseline and 12-week airflow rate and particle deposition will be analyzed with Computational Modeling Analysis. symptomatic improvement will be analyzed using SNOT-22 and NOSE questioners.

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: May 18, 2023
• Study Start: June 15, 2023
• Primary Completion: November 21, 2023
• Study Completion: December 21, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share