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

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Steroid-Eluting Sinexus Intranasal Splint
Sponsored by
Intersect ENT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Sinusitis focused on measuring Patients diagnosed with Chronic Sinusitis undergoing functional endoscopic surgery (FESS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central California Ear, Nose Thraot

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sinexus Intranasal Splint

Arm Description

Patient receives a drug-coated intranasal splint

Outcomes

Primary Outcome Measures

Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)
Device Placement Success Rate
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
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
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.

Full Information

First Posted
June 1, 2009
Last Updated
March 25, 2015
Sponsor
Intersect ENT
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1. Study Identification

Unique Protocol Identification Number
NCT00912405
Brief Title
Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
Official Title
A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intersect ENT

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
Patients diagnosed with Chronic Sinusitis undergoing functional endoscopic surgery (FESS)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sinexus Intranasal Splint
Arm Type
Experimental
Arm Description
Patient receives a drug-coated intranasal splint
Intervention Type
Device
Intervention Name(s)
Steroid-Eluting Sinexus Intranasal Splint
Intervention Description
Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Primary Outcome Measure Information:
Title
Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)
Time Frame
30 days
Title
Device Placement Success Rate
Description
A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.
Time Frame
At the time of procedure
Secondary Outcome Measure Information:
Title
Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities
Description
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.
Time Frame
Baseline and 30 days
Title
Number of Sinuses With Significant Post-operative Adhesion Formation
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Central California Ear, Nose Thraot
City
Fresno
State/Province
California
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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