Back to resultsA Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis (CONSENSUS II)
Primary Purpose
Chronic Sinusitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-coated Intranasal Splint
Sinexus Intranasal Splint
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sinusitis
Eligibility Criteria
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.
Sites / Locations
- Central California Ear, Nose, Throat
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Efficacy Unilateral Control
Efficacy Unilateral Treatment
Safety/PK Bilateral Treatment
Arm Description
Non-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator following FESS (control arm)
Drug-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the intervention following FESS (treatment arm)
Drug-coated splints placed bilaterally in both ethmoid sinus openings following FESS
Outcomes
Primary Outcome Measures
Device Success Rate
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.
Reduction in Ethmoid Sinus Inflammation
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 Outcome Measures
Middle Turbinate Lateralization
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.
Middle Meatus Patency
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).
Significant Adhesion Occurrence
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 *
Polypoid Tissue Changes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00840970
Brief Title
A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
Acronym
CONSENSUS II
Official Title
A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Rhinosinusitis (CRS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intersect ENT
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intra-patient control where one ethmoid sinus was randomized to receive the intervention (treatment arm) while the contralateral ethmoid received the active comparator (control arm)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Efficacy Unilateral Control
Arm Type
Active Comparator
Arm Description
Non-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator following FESS (control arm)
Arm Title
Efficacy Unilateral Treatment
Arm Type
Experimental
Arm Description
Drug-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the intervention following FESS (treatment arm)
Arm Title
Safety/PK Bilateral Treatment
Arm Type
Experimental
Arm Description
Drug-coated splints placed bilaterally in both ethmoid sinus openings following FESS
Intervention Type
Device
Intervention Name(s)
non-coated Intranasal Splint
Intervention Description
placement of non-coated intranasal splint following FESS
Intervention Type
Device
Intervention Name(s)
Sinexus Intranasal Splint
Intervention Description
placement of Sinexus Intranasal Splint placed following FESS
Primary Outcome Measure Information:
Title
Device Success Rate
Description
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.
Time Frame
Baseline
Title
Reduction in Ethmoid Sinus Inflammation
Description
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".
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Middle Turbinate Lateralization
Description
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.
Time Frame
30 days
Title
Middle Meatus Patency
Description
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).
Time Frame
30 days
Title
Significant Adhesion Occurrence
Description
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 *
Time Frame
30 days
Title
Polypoid Tissue Changes
Description
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.
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent Lanier, MD
Organizational Affiliation
Central California Ear, Nose, Throat
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central California Ear, Nose, Throat
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
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