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

NCT00912405 | Completed Results

• 1 other identifier: P500-0209
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Sinusitis

Keywords

Patients diagnosed with Chronic Sinusitis undergoing functional endoscopic surgery (FESS)

Outcome Measures

Primary Outcomes (2)

• Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)

  30 days

• 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

Secondary Outcomes (2)

• Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities

  Baseline and 30 days

• Number of Sinuses With Significant Post-operative Adhesion Formation

  30 days

Study Arms (1)

Sinexus Intranasal Splint

EXPERIMENTAL

Patient receives a drug-coated intranasal splint

Device: Steroid-Eluting Sinexus Intranasal Splint

Interventions

Steroid-Eluting Sinexus Intranasal Splint DEVICE

Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Sinexus Intranasal Splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intersect ENT: lead

Study Sites (1)

Central California Ear, Nose Thraot

Fresno, California, United States

Location

Results Point of Contact

• Title: James Stambaugh
• Organization: Intersect ENT

jstambaugh@intersectent.com

650-641-2103

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 20, 2015
• Results First Posted: April 20, 2015

Record last verified: 2015-03

Locations

US (1)