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

Chronic Sinusitis Clinical Trial

Official title:

A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912405
• Other study ID #: P500-0209
• Status: Completed
• Phase: N/A
• First received: June 1, 2009
• Last updated: March 25, 2015
• Start date: March 2009
• Est. completion date: December 2009

Study information

• Verified date: March 2015
• Source: Intersect ENT
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is 18 years of age or older

• Patient has a diagnosis of chronic sinusitis

• Patient has a clinical indication for and has consented to FESS

• Patient CT scan confirms CS diagnosis within 6 months of procedure

• CT sacn confirms presence of disease in ethmoid sinus(es)

• Planned FESS includes unilateral or bilateral total ethmoidectomy

Exclusion Criteria:

• Immune deficiency (IGG subclass deficiency or IGA deficiency)

• Oral-steroid dependent COPD, asthma or other condition

• Clinical evidence of acute bacterial sinusitis

• History or diagnosis of glaucoma or ocular hypertension

• Clinical evidence or suspicion of invasive fungal sinusitis

• Evidence of disease or condition expected to compromise survival or ability to complete follow-up

• Known history of allergy or intolerance to corticosteroids

• History of insulin dependent diabetes

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• Steroid-Eluting Sinexus Intranasal Splint
Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Locations

Country	Name	City	State
United States	Central California Ear, Nose Thraot	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	Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)		30 days	Yes
Primary	Device Placement Success Rate	A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.	At the time of procedure	No
Secondary	Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities	Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.	Baseline and 30 days	Yes
Secondary	Number of Sinuses With Significant Post-operative Adhesion Formation	Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.	30 days	No