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

NCT ID: NCT05156801

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-10-31

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.

Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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ArchSinus stent

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

Group Type EXPERIMENTAL

ArchSinus stent

Intervention Type DEVICE

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

Propel stent

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

Group Type ACTIVE_COMPARATOR

ArchSinus stent

Intervention Type DEVICE

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

NasoPore packing

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

Group Type ACTIVE_COMPARATOR

ArchSinus stent

Intervention Type DEVICE

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

Interventions

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ArchSinus stent

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

Intervention Type DEVICE

Other Intervention Names

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Composite Removable Sinus Stent System

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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STS Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Lena Shlossberg, MS

Role: CONTACT

Phone: +972526826962

Email: [email protected]

Other Identifiers

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461008P

Identifier Type: -

Identifier Source: org_study_id