Chronic SinusitisNCT05156801
Efficacy of ArchSinus, NasoPore & Propel to Prevent Post-Surgical MT Lateralization and Improve Symptomatic Outcomes
A study testing ArchSinus stent in people with Chronic Sinusitis, run by STS Medical.
Trial summary
This is a multi-center, randomized, single-blinded comparative 3-arm clinical study. This clinical study is designed to compare the efficacy of the ArchSinus stent to the Propel stent (Intersect ENT), and to NasoPore (Stryker) in preventing post-FESS middle turbinate lateralization 3 weeks, 6 weeks, 3 months and 12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- ArchSinus stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Oct 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
- Diagnosis of chronic rhinosinusitis defined as symptomatic inflammation of the sinuses of at least 12 consecutive weeks duration despite medical management
- CT scan examination with a minimum Zinreich score of 5 prior to study entry
- Less than 2-point Zinreich score difference between two sides
- Primary FESS including bilateral total ethmoidectomy; symmetrical uncinate process reduction
Who cannot join
- Inferior turbinectomy, reduction or outfracture
- Polyp grade ˃ 4 bilaterally on Lildholdt's scale (1-3)
- Concha bullosa
- Severe nasal septal deviation at the level of OMC
- Sinonasal tumors
- FESS including asymmetrical resection of the middle turbinate
Show all 17Show fewer
- Known allergy to nickel
- Known polyurethane induced dermatitis
- Oral steroid-dependent condition
- Momometasone furoate intolerance
- Known hypersensitivity to lactide, glycolide or caprolactone copolymers.
- Glaucoma or cataract
- History of immune deficiency
- Cystic fibrosis
- Pregnant or lactating female
- Acute sinus inflammation
- Coagulation disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of the ArchSinus, NasoPore and the Propel Stent in Preventing Post-Surgical Middle Turbinate Lateralization and Improving the Symptomatic Outcomes; Randomized, Blinded, Comparative Study
This is a multi-center, randomized, single-blinded comparative 3-arm clinical study. This clinical study is designed to compare the efficacy of the ArchSinus stent to the Propel stent (Intersect ENT), and to NasoPore (Stryker) in preventing post-FESS middle turbinate lateralization 3 weeks, 6 weeks, 3 months and 12 months post FESS.
Read the detailed description
50 chronic rhinosinusitis patients, that met the inclusion criteria will undergo bilateral FESS and subsequent bilateral placement of the ArchSinus into the randomized ethmoid sinus cavity and NasoPore / Propel into the other ethmoid sinus cavity. Comparative treatment sides will be randomly assigned; 50 sinuses treated with ArchSinus stent, 25 sinus treated with Propel stent, 25 sinuses treated with Nasopore. Standard Propel implant and 4cm whole NasoPore will be used.
ArchSinus stent will be removed 2 weeks (13-15 days) post FESS. Propel will be removed as necessary 2 weeks (13-15 days) post FESS. NasoPore arm will be debrided as necessary 2 weeks (13-15 days) post-FESS. Prior to removal / debridement procedures, the patients will be blindfolded, to keep them blinded for the treatment type on each side of their nose.
All patients will be followed up at 2, 6 and 12 weeks and 12 months post FESS and examined endoscopically. The endoscopic videos will be analyzed by independent pannel of 3 ENT surgeons, blinded to the treatment type, to assess middle turbinate lateralization on a 4-point scale.
CT scan will be performed pre-FESS and 12 weeks after the operation, to assess middle turbinate lateralization, as demonstrated by percent change in middle meatus (MM) area pre-FESS and 12 weeks after the surgery. Inflammatory mucosal thickening will be quantified using the Zinreich staging system. CT scans will be analyzed blindly by Medical Metrics Inc.
Symptomatic improvement will be analyzed weekly within 3 months follow up, using Side-specific Nasal SNOT-22 questioner.
Patient symptomatic relief during the implantation time will be analyzed 2 weeks post FESS, with Side-specific Nasal SNOT-22 questioner.
- Conditions
- Chronic Sinusitis
- Being tested
- ArchSinus stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArchSinus stentDevice
Also called Composite Removable Sinus Stent System
Post FESS unilateral placement of the ArchSinus stent into the randomized ethmoid sinus cavity.
| Study group | Role | What they receive |
|---|---|---|
| ArchSinus stent | Experimental | Post-FESS implantation of the study device (ArchSinus) into ethmoid sinus cavity Receives: Device: ArchSinus stent |
| Propel stent | Active comparator | Post-FESS implantation of the comparator device (Propel) into ethmoid sinus cavity. Receives: Device: ArchSinus stent |
| NasoPore packing | Active comparator | Post-FESS implantation of the comparator device (NasoPore) into ethmoid sinus cavity. Receives: Device: ArchSinus stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Middle turbinate lateralization 12 week post FESS (based CT scan)
The primary objective is to compare the efficacy of the ArchSinus to Propel stent (Intersect ENT), to prevent post-FESS middle turbinate lateralization, 12 weeks post-FESS, based on CT scan.
Measured: 12 weeks post FESS
Secondary outcomes (2)
Middle turbinate lateralization 12 week post FESS (based video endoscopy)
The secondary objective (1) is to compare the efficacy of the ArchSinus to the Propel stent (Intersect ENT), ), to prevent post-FESS middle turbinate lateralization, 12 weeks post-FESS, based on video endoscopy on a 4-point scale.
Measured: 12 weeks post FESS
Symptomatic outcomes within the 3-month post-FESS
The secondary objective (2) is to compare the efficacy of the ArchSinus to the Propel stent (Intersect ENT) in improving the symptomatic outcomes based on side-specific SNOT-22 questioner, within the 3-month follow-up.
Measured: 12 weeks post FESS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study startMar 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50 chronic rhinosinusitis patients, that met the inclusion criteria will undergo randomization into ArchSinus / Propel or ArchSinus / NasoPore implantation group. Comparative treatment sides will be randomly assigned; 13 subjects will be assigned to ArchSinus (right)/ Propel (left); 12 subjects will be assigned to ArchSinus (left)/ Propel (right); 12 subjects will be assigned to ArchSinus (right)/ NasoPore (left); 13 subjects will be assigned to ArchSinus (left)/ NasoPore (right) groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 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
- NCT05156801
- Sponsor's protocol ID
- 461008P
- Status last verified
- Nov 2021
- First submitted
- 29 Nov 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the ArchSinus, NasoPore and the Propel Stent in Preventing Post-Surgical Middle Turbinate Lateralization and Improving the Symptomatic Outcomes; Randomized, Blinded, Comparative Study
- ClinicalTrials.gov ID
- NCT05156801
- Acronym / sponsor ID
- 461008P
- Conditions
- Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- STS MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 14 Dec 2021 (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 multi-center, randomized, single-blinded comparative 3-arm clinical study. This clinical study is designed to compare the efficacy of the ArchSinus stent to the Propel stent (Intersect ENT), and to NasoPore (Stryker) in preventing post-FESS middle turbinate lateralization 3 weeks, 6 weeks, 3 months and 12 months post FESS.
Detailed description
50 chronic rhinosinusitis patients, that met the inclusion criteria will undergo bilateral FESS and subsequent bilateral placement of the ArchSinus into the randomized ethmoid sinus cavity and NasoPore / Propel into the other ethmoid sinus cavity. Comparative treatment sides will be randomly assigned; 50 sinuses treated with ArchSinus stent, 25 sinus treated with Propel stent, 25 sinuses treated with Nasopore. Standard Propel implant and 4cm whole NasoPore will be used.
ArchSinus stent will be removed 2 weeks (13-15 days) post FESS. Propel will be removed as necessary 2 weeks (13-15 days) post FESS. NasoPore arm will be debrided as necessary 2 weeks (13-15 days) post-FESS. Prior to removal / debridement procedures, the patients will be blindfolded, to keep them blinded for the treatment type on each side of their nose.
All patients will be followed up at 2, 6 and 12 weeks and 12 months post FESS and examined endoscopically. The endoscopic videos will be analyzed by independent pannel of 3 ENT surgeons, blinded to the treatment type, to assess middle turbinate lateralization on a 4-point scale.
CT scan will be performed pre-FESS and 12 weeks after the operation, to assess middle turbinate lateralization, as demonstrated by percent change in middle meatus (MM) area pre-FESS and 12 weeks after the surgery. Inflammatory mucosal thickening will be quantified using the Zinreich staging system. CT scans will be analyzed blindly by Medical Metrics Inc.
Symptomatic improvement will be analyzed weekly within 3 months follow up, using Side-specific Nasal SNOT-22 questioner.
Patient symptomatic relief during the implantation time will be analyzed 2 weeks post FESS, with Side-specific Nasal SNOT-22 questioner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 50 chronic rhinosinusitis patients, that met the inclusion criteria will undergo randomization into ArchSinus / Propel or ArchSinus / NasoPore implantation group. Comparative treatment sides will be randomly assigned; 13 subjects will be assigned to ArchSinus (right)/ Propel (left); 12 subjects will be assigned to ArchSinus (left)/ Propel (right); 12 subjects will be assigned to ArchSinus (right)/ NasoPore (left); 13 subjects will be assigned to ArchSinus (left)/ NasoPore (right) groups.
| Arm | Type | Receives |
|---|---|---|
| ArchSinus stent | Experimental | Device: ArchSinus stentPost-FESS implantation of the study device (ArchSinus) into ethmoid sinus cavity |
| Propel stent | Active comparator | Device: ArchSinus stentPost-FESS implantation of the comparator device (Propel) into ethmoid sinus cavity. |
| NasoPore packing | Active comparator | Device: ArchSinus stentPost-FESS implantation of the comparator device (NasoPore) into ethmoid sinus cavity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of chronic rhinosinusitis defined as symptomatic inflammation of the sinuses of at least 12 consecutive weeks duration despite medical management
- CT scan examination with a minimum Zinreich score of 5 prior to study entry
- Less than 2-point Zinreich score difference between two sides
- Primary FESS including bilateral total ethmoidectomy; symmetrical uncinate process reduction
Key exclusion criteria (17 listed)
- Inferior turbinectomy, reduction or outfracture
- Polyp grade ˃ 4 bilaterally on Lildholdt's scale (1-3)
- Concha bullosa
- Severe nasal septal deviation at the level of OMC
- Sinonasal tumors
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 stentAlso: Composite Removable Sinus Stent SystemPost FESS unilateral placement of the ArchSinus stent into the randomized ethmoid sinus cavity. | Device | ArchSinus stent, NasoPore packing, Propel stent |
Primary outcome
Middle turbinate lateralization 12 week post FESS (based CT scan)
Time frame: 12 weeks post FESS
The primary objective is to compare the efficacy of the ArchSinus to Propel stent (Intersect ENT), to prevent post-FESS middle turbinate lateralization, 12 weeks post-FESS, based on CT scan.
2 secondary outcomes
Middle turbinate lateralization 12 week post FESS (based video endoscopy)
Time frame: 12 weeks post FESS
Symptomatic outcomes within the 3-month post-FESS
Time frame: 12 weeks post FESS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
Related trials for Chronic Sinusitis
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Not yet recruiting
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Sinusitis Chronic, Postoperative Care
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.
Questions about this trial
What is this clinical trial studying?
A study testing ArchSinus stent in people with Chronic Sinusitis, 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 4 inclusion and 17 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 14 Dec 2021. 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?
Contact Lena Shlossberg, MS (+972526826962, lena@ststent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Middle turbinate lateralization 12 week post FESS (based CT scan) (time frame: 12 weeks post FESS). 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 14 Dec 2021.