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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intersect ENT
ClinicalTrials.gov Identifier:
NCT00912405
First received: June 1, 2009
Last updated: March 25, 2015
Last verified: March 2015
  Purpose

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).


Condition Intervention
Chronic Sinusitis
Device: Steroid-Eluting Sinexus Intranasal Splint

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

Resource links provided by NLM:


Further study details as provided by Intersect ENT:

Primary Outcome Measures:
  • Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Device Placement Success Rate [ Time Frame: At the time of procedure ] [ Designated as safety issue: No ]
    A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.


Secondary Outcome Measures:
  • Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities [ Time Frame: Baseline and 30 days ] [ Designated as safety issue: Yes ]
    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.

  • Number of Sinuses With Significant Post-operative Adhesion Formation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sinexus Intranasal Splint
Patient receives a drug-coated intranasal splint
Device: Steroid-Eluting Sinexus Intranasal Splint
Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912405

Locations
United States, California
Central California Ear, Nose Thraot
Fresno, California, United States
Sponsors and Collaborators
Intersect ENT
  More Information

No publications provided

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT00912405     History of Changes
Other Study ID Numbers: P500-0209
Study First Received: June 1, 2009
Results First Received: October 23, 2014
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Intersect ENT:
Patients diagnosed with Chronic Sinusitis undergoing functional endoscopic surgery (FESS)

Additional relevant MeSH terms:
Chronic Disease
Sinusitis
Disease Attributes
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 01, 2015