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

Chronic Sinusitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05156801
• Other study ID #: 461008P
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: October 2023

Study information

• Verified date: November 2021
• Source: STS Medical
• Contact: Lena Shlossberg, MS
• Phone: +972526826962
• Email: lena[@]ststent.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 months post FESS.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
STS Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Removal time	Compare ArchSinus and Propel removal time	2 weeks post FESS
Other	Inflammatory mucosal thickening	Compare % change of inflammatory mucosal thickening 12 weeks post FESS in ArchSinus / Propel / NasoPore implanted sinuses	12 weeks post FESS
Other	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
Primary	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	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
Secondary	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