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

Intersect ENT

Status: Completed

Conditions: Chronic Sinusitis

Treatments: Device: non-coated Intranasal Splint; Device: Sinexus Intranasal Splint

Study type: Interventional

Funder types: Industry

Identifiers

NCT00840970

P500-0208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 3 patient groups

Efficacy Unilateral Control

Active Comparator group

Description:

Non-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator following FESS (control arm)

Treatment:

Device: non-coated Intranasal Splint

Efficacy Unilateral Treatment

Experimental group

Description:

Drug-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the intervention following FESS (treatment arm)

Treatment:

Device: Sinexus Intranasal Splint

Safety/PK Bilateral Treatment

Experimental group

Description:

Drug-coated splints placed bilaterally in both ethmoid sinus openings following FESS

Treatment:

Device: Sinexus Intranasal Splint