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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Device: ArchSinus stent

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lena Shlossberg, MS; Phone Number: +972526826962; Email: lena@ststent.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-stenosis rate 6 weeks post FESS (based video endoscopy)	(1) Compare re-stenosis rate in ArchSinus / Propel / NasoPore implanted sinuses assessed on a 1 to 4 scale based on nasal endoscopy at week 6	6 weeks post FESS
symptomatic relief 2 weeks post FESS	Compare symptomatic relief in ArchSinus / Propel / NasoPore implanted sinuses, based side - specific Nasal SNOT-22 score 2 weeks post-FESS.	2 weeks post FESS
Removal time	Compare ArchSinus and Propel removal time	2 weeks post FESS
Inflammatory mucosal thickening	Compare % change of inflammatory mucosal thickening 12 weeks post FESS in ArchSinus / Propel / NasoPore implanted sinuses	12 weeks post FESS
Re-stenosis rate 12 months post FESS	Compare re-stenosis rate in ArchSinus / Propel / NasoPore implanted sinuses assessed on a 1 to 4 scale based on nasal endoscopy 12 months post FESS.	12 months post FESS

Collaborators and Investigators

• Sponsor: STS Medical

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 12, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: 461008P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No