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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efficacy Unilateral Control | Active Comparator | Non-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator following FESS (control arm) |
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| Efficacy Unilateral Treatment | Experimental | Drug-coated splint placed unilaterally in the ethmoid sinus opening randomized to receive the intervention following FESS (treatment arm) |
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| Safety/PK Bilateral Treatment | Experimental | Drug-coated splints placed bilaterally in both ethmoid sinus openings following FESS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-coated Intranasal Splint | Device | placement of non-coated intranasal splint following FESS |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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". | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brent Lanier, MD | Central California Ear, Nose, Throat | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California Ear, Nose, Throat | Fresno | California | 93720 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pilot 15 mm | First 7 patients (n=7) in the Pilot Phase received 15 mm length splint. This phase used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint (15mm length, 220 ug mometasone furoate [MF]) was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm). 15 mm length splint was not commercialized. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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)
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| Sinexus Intranasal Splint | Device | placement of Sinexus Intranasal Splint placed following FESS |
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| 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). | 30 days |
| 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 * | 30 days |
| 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. | 30 days |
| FG001 | Efficacy 25 mm | Efficacy group received the 25mm splint in the Pilot (n=13) and Pivotal Phases (n=25). Both phases used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint (25 mm length, 370 ug MF) was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm). |
| FG002 | Safety/PK 25 mm | Safety/PK group (n=5) used a non-randomized design wherein following FESS a drug-coated splints (25 mm length with 370 ug MF) were placed bilaterally in both ethmoid sinus openings. |
| COMPLETED |
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| NOT COMPLETED |
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Analysis prespecified for Efficacy 25 mm (Pivotal n=25) and all patients only. They cannot be specified per group.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All Patients includes the Pilot 15 mm (n=7), Efficacy 25 mm (n=38 [Pilot n=13,Pivotal Phases n=25]) and Safety/PK 25 mm (n=5) groups. Pilot 15 mm and Efficacy 25 mm groups used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm). In Pilot 15 mm group, patients in treatment arm received a 15mm length splint (220ug MF). In Efficacy 25 mm group, patients in the treatment arm received a 25mm length splint (370ug MF). Safety/PK group used a non-randomized design wherein following FESS a drug-coated splints (25 mm length with 370 ug MF) were placed bilaterally in both ethmoid sinus openings. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| History of smoking | Count of Participants | Participants |
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| Symptoms pre-op | Count of Participants | Participants |
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| Number of prior sinus procedures | Count of Participants | Participants |
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| Lund-Mackay score | The Lund-Mackay score is used to assess chronic rhinosinusitis. Each sinus (frontal, anterior ethmoidal cells, posterior ethmoidal cells, maxillary sinus, and sphenoid sinus) is scored from 0 (no abnormality), 1 (partial opacification) to 2 (complete opacification). The ostiomeatal complex is scored from 0 (not obstructed) to 2 (obstructed). Each side is graded separately. A combined score of up to 24 is possible. | Mean | Standard Deviation | units on a scale |
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| Polyps | Polyps at baseline is defined as either the right or left ethmoid having a polyp grade > 0 | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis per patient. | Posted | Count of Units | ethmoid sinuses | Baseline | ethmoid sinuses | ethmoid sinuses |
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| Primary | 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". | This measure only analyzed for Efficacy 25 mm splint (n=38). Efficacy 15 mm splint (n=7) not analyzed since it was not commercialized. Safety/PK (n=5) only evaluated for safety data. | Posted | Mean | Standard Deviation | units on a scale | 21 days | ethmoid sinuses | ethmoid sinuses |
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| Secondary | 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. | This measure only analyzed for Efficacy 25 mm splint (n=38). Efficacy 15 mm splint (n=7) not analyzed since it was not commercialized. Safety/PK (n=5) only evaluated for safety data. | Posted | Count of Units | ethmoid sinuses | 30 days | ethmoid sinuses | ethmoid sinuses |
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| Secondary | 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). | This measure only analyzed for Efficacy 25 mm splint (n=38). Efficacy 15 mm splint (n=7) not analyzed since it was not commercialized. Safety/PK (n=5) only evaluated for safety data. | Posted | Count of Units | ethmoid sinuses | 30 days | ethmoid sinuses | ethmoid sinuses |
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| Secondary | 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 * | This measure only analyzed for Efficacy 25 mm splint (n=38). Efficacy 15 mm splint (n=7) not analyzed since it was not commercialized. Safety/PK (n=5) only evaluated for safety data. | Posted | Count of Units | ethmoid sinuses | 30 days | ethmoid sinuses | ethmoid sinuses |
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| Secondary | 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. | This measure only analyzed for Efficacy 25 mm splint (n=38). Efficacy 15 mm splint (n=7) not analyzed since it was not commercialized. Safety/PK (n=5) only evaluated for safety data. | Posted | Count of Units | ethmoid sinuses | 30 days | ethmoid sinuses | ethmoid sinuses |
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30 days
Serious Adverse Local Tissue (SALT) response is defined as an adverse effect (bleeding, burning, or infection) occurring in the tissue of the splinted sinus cavity that is serious enough in nature or intensity as to require removal of the Sinexus intranasal splint to resolve.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot 15 mm | First 7 patients (n=7) in the Pilot Phase received 15 mm length splint. This phase used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint (15mm length, 220 ug mometasone furoate [MF]) was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm). 15 mm length splint was not commercialized. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG001 | Efficacy 25 mm | Efficacy group received the 25mm splint in the Pilot (n=13) and Pivotal Phases (n=25). Both phases used a randomized intra-patient design wherein following FESS a non-coated splint was placed unilaterally in the ethmoid sinus opening randomized to receive the active comparator (control arm), and the drug-coated Sinexus Splint (25 mm length, 370 ug MF) was placed contralaterally in the ethmoid sinus opening randomized to receive the intervention (treatment arm). | 0 | 38 | 0 | 38 | 0 | 38 |
| EG002 | Safety/PK 25 mm | Safety/PK group (n=5) used a non-randomized design wherein following FESS a drug-coated splints (25 mm length with 370 ug MF) were placed bilaterally in both ethmoid sinus openings. | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Lewis, VP Clinical Affairs | Intersect ENT | 423-598-6681 | clewis@intersectent.com |
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| Current smoker |
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| Cough |
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| Dental pain |
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| Headache |
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| Fatigue |
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| Halitosis |
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| Ear pain, pressure, fullness |
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| Anosmia |
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| Facial pain, pressure, other |
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| Other |
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| 2 |
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| 3 |
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| >=4 |
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| Left |
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| Total |
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| Participants |
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| ethmoid sinuses |
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| ethmoid sinuses |
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| ethmoid sinuses |
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| ethmoid sinuses |
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| Participants |
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| ethmoid sinuses |
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