Chronic Sinusitis, EthmoidalNCT05863468
Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation
A study testing ArchSinus implantation in people with Chronic Sinusitis, Ethmoidal, run by STS Medical.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis, Ethmoidal
- What is being tested?
- ArchSinus implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnant or lactating female
- Acute sinus inflammation
- Coagulation disorders
About this study
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.
Read the 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
- Being tested
- ArchSinus implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArchSinus implantationDevice
Unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation
| Study group | Role | What they receive |
|---|---|---|
| ArchSinus implantation | Experimental | Subjects will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation Receives: Device: ArchSinus implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion21 Nov 2023 (estimated)
- Study completion21 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Sinusitis, EthmoidalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- STS Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863468
- Sponsor's protocol ID
- 461010P
- Status last verified
- Jan 2023
- First submitted
- 29 Jan 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation
- ClinicalTrials.gov ID
- NCT05863468
- Acronym / sponsor ID
- 461010P
- Conditions
- Chronic Sinusitis, Ethmoidal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- STS MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 21 Nov 2023 (estimated)
- Study completion
- 21 Dec 2023 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| ArchSinus implantation | Experimental | Device: ArchSinus implantationSubjects will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Polyp grade ˃ 4 bilaterally on Lildholdt's scale (1-3)
- Sinonasal tumors
- Known allergy to nickel
- Known polyurethane induced dermatitis
- History of immune deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArchSinus implantationUnilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation | Device | ArchSinus implantation |
Primary outcome
Sinus airflow and particle deposition rate
Time frame: 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.
1 secondary outcome
Symptomatic improvement
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ArchSinus implantation in people with Chronic Sinusitis, Ethmoidal, run by STS Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinus airflow and particle deposition rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.