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Completed

NCT Number: NCT00840970

A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis

The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.

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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, Throat

Fresno, California, 93720, United States

About this study

This was a prospective, multi-center, double blind trial that enrolled patients in three groups as described below. Two groups (Pilot 15 mm and Efficacy 25 mm) used a randomized, double-blind, intra-patient control study design to assess performance of the drug-coated Splint (received in one ethmoid sinus) compared to the control Splint (received in the contralateral ethmoid). The other group of patients (Safety/PK 25 mm) received bilateral drug-coated Splints, and served as a pharmacokinetics (PK) study group.

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 bilateral CRS defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration.
  • Patient has a clinical indication for and has consented to bilateral FESS.
  • CRS diagnosis documented by CT scan within 60 days of the procedure.
  • Patient has minimal total CT stage (Lund-Mackay method) of 6.
  • Patient has bilateral disease defined as minimal CT stage per side of ≥3.

Exclusion criteria

  • Oral-Steroid dependent COPD, asthma or other condition.
  • Immune deficiency (IGG subclass deficiency or IGA deficiency).
  • Symptomatic coronary artery disease.
  • Patient undergoing chemotherapy treatment.
  • Morbid obesity (BMI > 40) or a BMI that, in the opinion of the physician, would compromise health and participation in the study.
  • Evidence of active infection.

Treatment and study plan

non-coated Intranasal Splint

Device

placement of non-coated intranasal splint following FESS

Sinexus Intranasal Splint

Device

placement of Sinexus Intranasal Splint placed following FESS

Primary outcomes

  1. Device Success Rate

    Time frame: Baseline

    Device success rate defined as a ratio where the numerator is the number of successful deployments of the Sinexus Intranasal Splint and the denominator is the number of attempted sinuses. Deployment was considered successful if the implant procedure concluded with a successful splint placement on the intended side.

  2. Reduction in Ethmoid Sinus Inflammation

    Time frame: 21 days

    Inflammation was scored by the physician using a 100-mm Visual Analog Scale (VAS) during endoscopic evaluation with range of 0 to 100mm. The term inflammation was used as a global descriptor defined to include mucosal edema, erythema, hypertrophy and polypoid changes. 0 represented no inflammation and 100mm was defined as "Severe, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes".

Secondary outcomes

  1. Middle Turbinate Lateralization

    Time frame: 30 days

    Position of the middle turbinate was assessed using a 4-point categorical scale (medialized, normal, partially lateralized, lateralized). For Lateralized Middle Turbinate, a sinus is counted once if this occurs at least once during the 30 Day timeframe. Lateralized Middle Turbinate (worse outcome), if left unaddressed, is often the cause of sinus obstruction.

  2. Middle Meatus Patency

    Time frame: 30 days

    Patency of the middle meatus was assessed using a 3-point categorical scale (patent, narrowed, obstructed). Analysis included patent (better outcome) vs narrowed/obstructed (worse outcome).

  3. Significant Adhesion Occurrence

    Time frame: 30 days

    Adhesion formation was assessed using a 5-point categorical scale (none, small/non-obstructing, obstructing/easily separated, *dense/obstructing/difficult to separate, *severe/complete adhesion to lateral nasal wall) with "significant adhesion" denoted by *

  4. Polypoid Tissue Changes

    Time frame: 30 days

    Polyp formation in the ethmoid sinus assessed using an accepted 5-point categorical scale: 0-no visible nasal polyp (NP), 1-small amount NP confined in the middle meatus (MM); 2-multiple NP confined in MM; 3-NP extending beyond MM, within the sphenoethmoid recess not totally obstructing, or both; 4-NP completely obstructing the nasal cavity. 0 is best, and 4 is worst. When a patient's sinus has a change in polyp score at Day 30 it is counted as one.

Sponsors and collaborators

Lead sponsor

Intersect ENT

Industry

Registry information

Official study title

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

Acronym: CONSENSUS II

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 11, 2009
Registry last updated
Oct 1, 2020

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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