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Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation

Sponsor
STS Medical (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05863468
Collaborator
(none)
4
Enrollment
1
Arm
6.2
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ArchSinus implantation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation
Anticipated Study Start Date :
Jun 15, 2023
Anticipated Primary Completion Date :
Nov 21, 2023
Anticipated Study Completion Date :
Dec 21, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Sinus airflow and particle deposition rate [12 weeks]

    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.

Secondary Outcome Measures

  1. Symptomatic improvement [12 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • STS Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
STS Medical
ClinicalTrials.gov Identifier:
NCT05863468
Other Study ID Numbers:
  • 461010P
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Sinusitis
Ethmoid Sinusitis

Study Results

No Results Posted as of May 18, 2023