A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis

Intersect ENT50 enrolled

Overview

The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.

This was a prospective, multi-center, double blind trial that enrolled patients in three groups as described below. Two groups (Pilot 15 mm and Efficacy 25 mm) used a randomized, double-blind, intra-patient control study design to assess performance of the drug-coated Splint (received in one ethmoid sinus) compared to the control Splint (received in the contralateral ethmoid). The other group of patients (Safety/PK 25 mm) received bilateral drug-coated Splints, and served as a pharmacokinetics (PK) study group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Sinusitis

Interventions

non-coated Intranasal SplintDEVICE

placement of non-coated intranasal splint following FESS

Sinexus Intranasal SplintDEVICE

placement of Sinexus Intranasal Splint placed following FESS

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is 18 years of age or older. * Patient has a diagnosis of bilateral CRS defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration. * Patient has a clinical indication for and has consented to bilateral FESS. * CRS diagnosis documented by CT scan within 60 days of the procedure. * Patient has minimal total CT stage (Lund-Mackay method) of 6. * Patient has bilateral disease defined as minimal CT stage per side of ≥3. Exclusion Criteria: * Oral-Steroid dependent COPD, asthma or other condition. * Immune deficiency (IGG subclass deficiency or IGA deficiency). * Symptomatic coronary artery disease. * Patient undergoing chemotherapy treatment. * Morbid obesity (BMI \> 40) or a BMI that, in the opinion of the physician, would compromise health and participation in the study. * Evidence of active infection.

Locations (1)

Central California Ear, Nose, Throat

Fresno, California, United States

Outcomes

Primary Outcomes

Device Success Rate

Device success rate defined as a ratio where the numerator is the number of successful deployments of the Sinexus Intranasal Splint and the denominator is the number of attempted sinuses. Deployment was considered successful if the implant procedure concluded with a successful splint placement on the intended side.

Time frame: Baseline

Reduction in Ethmoid Sinus Inflammation

Inflammation was scored by the physician using a 100-mm Visual Analog Scale (VAS) during endoscopic evaluation with range of 0 to 100mm. The term inflammation was used as a global descriptor defined to include mucosal edema, erythema, hypertrophy and polypoid changes. 0 represented no inflammation and 100mm was defined as "Severe, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes".

Time frame: 21 days

Secondary Outcomes

Middle Turbinate Lateralization

Position of the middle turbinate was assessed using a 4-point categorical scale (medialized, normal, partially lateralized, lateralized). For Lateralized Middle Turbinate, a sinus is counted once if this occurs at least once during the 30 Day timeframe. Lateralized Middle Turbinate (worse outcome), if left unaddressed, is often the cause of sinus obstruction.

Time frame: 30 days

Middle Meatus Patency

Patency of the middle meatus was assessed using a 3-point categorical scale (patent, narrowed, obstructed). Analysis included patent (better outcome) vs narrowed/obstructed (worse outcome).

Time frame: 30 days

Significant Adhesion Occurrence

Adhesion formation was assessed using a 5-point categorical scale (none, small/non-obstructing, obstructing/easily separated, \*dense/obstructing/difficult to separate, \*severe/complete adhesion to lateral nasal wall) with "significant adhesion" denoted by \*

Data from ClinicalTrials.gov

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