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

Chronic Sinusitis Clinical Trial

— CONSENSUS II  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840970
• Other study ID #: P500-0208
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: April 2009

Study information

• Verified date: September 2020
• Source: Intersect ENT
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• non-coated Intranasal Splint
placement of non-coated intranasal splint following FESS
• Sinexus Intranasal Splint
placement of Sinexus Intranasal Splint placed following FESS

Locations

Country	Name	City	State
United States	Central California Ear, Nose, Throat	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
Intersect ENT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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