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

A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Rhinosinusitis (CRS)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Device: non-coated Intranasal Splint; Device: Sinexus Intranasal Splint

Detailed Description

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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Central California Ear, Nose, Throat

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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Efficacy Unilateral Control; Non-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator following FESS (control arm)	Device: non-coated Intranasal Splint; placement of non-coated intranasal splint following FESS
Experimental: Efficacy Unilateral Treatment; Drug-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the intervention following FESS (treatment arm)	Device: Sinexus Intranasal Splint; placement of Sinexus Intranasal Splint placed following FESS
Experimental: Safety/PK Bilateral Treatment; Drug-coated splints placed bilaterally in both ethmoid sinus openings following FESS	Device: Sinexus Intranasal Splint; placement of Sinexus Intranasal Splint placed following FESS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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".	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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 *	30 days
Polypoid Tissue Changes	Polyp formation in the ethmoid sinus assessed using an accepted 5-point categorical scale: 0-no visible nasal polyp (NP), 1-small amount NP confined in the middle meatus (MM); 2-multiple NP confined in MM; 3-NP extending beyond MM, within the sphenoethmoid recess not totally obstructing, or both; 4-NP completely obstructing the nasal cavity. 0 is best, and 4 is worst. When a patient's sinus has a change in polyp score at Day 30 it is counted as one.	30 days

Collaborators and Investigators

• Sponsor: Intersect ENT
• Investigators: Principal Investigator: Brent Lanier, MD, Central California Ear, Nose, Throat

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: February 9, 2009
• First Submitted That Met QC Criteria: February 10, 2009
• First Posted (Estimate): February 11, 2009

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

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: P500-0208