Clinical trial NCT00840970: A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
Official title: A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Rhinosinusitis (CRS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Lead sponsor: Intersect ENT
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-patient control where one ethmoid sinus was randomized to receive the intervention (treatment arm) while the contralateral ethmoid received the active comparator (control arm)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Device Success Rate
timeFrame: Baseline
measure: Reduction in Ethmoid Sinus Inflammation
timeFrame: 21 days
Secondary outcomes:
measure: Middle Turbinate Lateralization
timeFrame: 30 days
measure: Middle Meatus Patency
timeFrame: 30 days
measure: Significant Adhesion Occurrence
timeFrame: 30 days
measure: Polypoid Tissue Changes
timeFrame: 30 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central California Ear, Nose, Throat
state: California
Study officials:
affiliation: Central California Ear, Nose, Throat
name: Brent Lanier, MD
role: PRINCIPAL_INVESTIGATOR
References: