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

NCT05156801 | Unknown

• 1 other identifier: 461008P
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 months post FESS.

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Middle turbinate lateralization 12 week post FESS (based video endoscopy)

  12 weeks post FESS

• Symptomatic outcomes within the 3-month post-FESS

  12 weeks post FESS

Other Outcomes (5)

• Re-stenosis rate 6 weeks post FESS (based video endoscopy)

  6 weeks post FESS

• symptomatic relief 2 weeks post FESS

  2 weeks post FESS

• Removal time

  2 weeks post FESS

Study Arms (3)

ArchSinus stent

EXPERIMENTAL

Post-FESS implantation of the study device (ArchSinus) into ethmoid sinus cavity

Device: ArchSinus stent

Propel stent

ACTIVE COMPARATOR

Post-FESS implantation of the comparator device (Propel) into ethmoid sinus cavity.

Device: ArchSinus stent

NasoPore packing

ACTIVE COMPARATOR

Post-FESS implantation of the comparator device (NasoPore) into ethmoid sinus cavity.

Device: ArchSinus stent

Interventions

ArchSinus stent DEVICE

Post FESS unilateral placement of the ArchSinus stent into the randomized ethmoid sinus cavity.

Also known as: Composite Removable Sinus Stent System

ArchSinus stent; NasoPore packing; Propel stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• STS Medical: lead

Central Study Contacts

Lena Shlossberg, MS

CONTACT

+972526826962; lena@ststent.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Primary objective will be analyzed using nasal video endoscopy and a CT scan, by an external experts in a blinded fashion. Secondary objective will be analyzed using side-specific SNOT-22 questioner, subjects will be blinded to the treatment type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 14, 2021
• Study Start: March 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 14, 2021

Record last verified: 2021-11