Efficacy of ArchSinus, NasoPore & Propel to Prevent Post-Surgical MT Lateralization and Improve Symptomatic Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Device: ArchSinus stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ArchSinus stent<br>Post-FESS implantation of the study device (ArchSinus) into ethmoid sinus cavity | Device: ArchSinus stent<br>* Post FESS unilateral placement of the ArchSinus stent into the randomized ethmoid sinus cavity.<br>* Other names: Composite Removable Sinus Stent System;|
| Active Comparator: Propel stent<br>Post-FESS implantation of the comparator device (Propel) into ethmoid sinus cavity. | Device: ArchSinus stent<br>* Post FESS unilateral placement of the ArchSinus stent into the randomized ethmoid sinus cavity.<br>* Other names: Composite Removable Sinus Stent System;|
| Active Comparator: NasoPore packing<br>Post-FESS implantation of the comparator device (NasoPore) into ethmoid sinus cavity. | Device: ArchSinus stent<br>* Post FESS unilateral placement of the ArchSinus stent into the randomized ethmoid sinus cavity.<br>* Other names: Composite Removable Sinus Stent System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks post FESS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 weeks post FESS |