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

NCT ID: NCT00840970

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-04-30

Brief Summary

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.

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.

Conditions

Chronic Sinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Efficacy Unilateral Control

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

Group Type: ACTIVE_COMPARATOR

non-coated Intranasal Splint

Intervention Type: DEVICE

placement of non-coated intranasal splint following FESS

Efficacy Unilateral Treatment

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

Group Type: EXPERIMENTAL

Sinexus Intranasal Splint

Intervention Type: DEVICE

placement of Sinexus Intranasal Splint placed following FESS

Safety/PK Bilateral Treatment

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

Group Type: EXPERIMENTAL

Sinexus Intranasal Splint

Intervention Type: DEVICE

placement of Sinexus Intranasal Splint placed following FESS

Interventions

non-coated Intranasal Splint

placement of non-coated intranasal splint following FESS

Intervention Type: DEVICE

Sinexus Intranasal Splint

placement of Sinexus Intranasal Splint placed following FESS

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intersect ENT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brent Lanier, MD

Role: PRINCIPAL_INVESTIGATOR

Central California Ear, Nose, Throat

Locations

Central California Ear, Nose, Throat

Fresno, California, United States

Countries

United States

Other Identifiers

P500-0208

Identifier Type: -

Identifier Source: org_study_id