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Completed

NCT Number: NCT00912405

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

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).

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Key information

Conditions

Chronic Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central California Ear, Nose Thraot

Fresno, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Steroid-Eluting Sinexus Intranasal Splint

Device

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

Primary outcomes

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

    Time frame: 30 days

  2. Device Placement Success Rate

    Time frame: At the time of procedure

    A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.

Secondary outcomes

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

    Time frame: Baseline and 30 days

    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.

  2. Number of Sinuses With Significant Post-operative Adhesion Formation

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Intersect ENT

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 3, 2009
Registry last updated
Apr 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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