Trial Outcomes & Findings for A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis (NCT NCT00840970)
NCT ID: NCT00840970
Last Updated: 2020-10-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline
Results posted on
2020-10-01
Participant Flow
Unit of analysis: ethmoid sinuses
Participant milestones
| Measure |
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.
|
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).
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7 14
|
38 76
|
5 10
|
|
Overall Study
COMPLETED
|
7 14
|
38 76
|
4 8
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
1 2
|
Reasons for withdrawal
| Measure |
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.
|
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).
|
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Patients
n=50 Participants
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.
|
|---|---|
|
Lund-Mackay score
Left
|
6.9 units on a scale
STANDARD_DEVIATION 2.2 • n=50 Participants
|
|
Lund-Mackay score
Total
|
13.6 units on a scale
STANDARD_DEVIATION 4.1 • n=50 Participants
|
|
Polyps
|
38 Participants
n=50 Participants
|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 15.5 • n=50 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=50 Participants
|
|
History of smoking
Never smoked
|
40 Participants
n=50 Participants
|
|
History of smoking
Previous smoker, stopped > 1 year ago
|
5 Participants
n=50 Participants
|
|
History of smoking
Current smoker
|
5 Participants
n=50 Participants
|
|
Symptoms pre-op
Nasal obstruction/congestion
|
40 Participants
n=50 Participants
|
|
Symptoms pre-op
Discolored nasal discharge
|
11 Participants
n=50 Participants
|
|
Symptoms pre-op
Cough
|
9 Participants
n=50 Participants
|
|
Symptoms pre-op
Dental pain
|
3 Participants
n=50 Participants
|
|
Symptoms pre-op
Headache
|
17 Participants
n=50 Participants
|
|
Symptoms pre-op
Fatigue
|
6 Participants
n=50 Participants
|
|
Symptoms pre-op
Halitosis
|
3 Participants
n=50 Participants
|
|
Symptoms pre-op
Ear pain, pressure, fullness
|
6 Participants
n=50 Participants
|
|
Symptoms pre-op
Anosmia
|
15 Participants
n=50 Participants
|
|
Symptoms pre-op
Facial pain, pressure, other
|
20 Participants
n=50 Participants
|
|
Symptoms pre-op
Other
|
22 Participants
n=50 Participants
|
|
Number of prior sinus procedures
0
|
29 Participants
n=50 Participants
|
|
Number of prior sinus procedures
1
|
13 Participants
n=50 Participants
|
|
Number of prior sinus procedures
2
|
7 Participants
n=50 Participants
|
|
Number of prior sinus procedures
3
|
0 Participants
n=50 Participants
|
|
Number of prior sinus procedures
>=4
|
1 Participants
n=50 Participants
|
|
Lund-Mackay score
Right
|
6.8 units on a scale
STANDARD_DEVIATION 2.3 • n=50 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Analysis per patient.
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.
Outcome measures
| Measure |
Pilot 15 mm
n=14 ethmoid sinuses
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.
|
Efficacy 25 mm
n=76 ethmoid sinuses
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).
|
Safety/PK 25 mm
n=10 ethmoid sinuses
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.
|
|---|---|---|---|
|
Device Success Rate
|
14 ethmoid sinuses
|
76 ethmoid sinuses
|
10 ethmoid sinuses
|
PRIMARY outcome
Timeframe: 21 daysPopulation: 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.
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".
Outcome measures
| Measure |
Pilot 15 mm
n=38 ethmoid sinuses
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.
|
Efficacy 25 mm
n=38 ethmoid sinuses
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).
|
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.
|
|---|---|---|---|
|
Reduction in Ethmoid Sinus Inflammation
|
23.2 units on a scale
Standard Deviation 17.7
|
35.3 units on a scale
Standard Deviation 21.8
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Pilot 15 mm
n=38 ethmoid sinuses
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.
|
Efficacy 25 mm
n=38 ethmoid sinuses
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).
|
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.
|
|---|---|---|---|
|
Middle Turbinate Lateralization
|
2 ethmoid sinuses
|
6 ethmoid sinuses
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
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).
Outcome measures
| Measure |
Pilot 15 mm
n=38 ethmoid sinuses
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.
|
Efficacy 25 mm
n=38 ethmoid sinuses
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).
|
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.
|
|---|---|---|---|
|
Middle Meatus Patency
|
37 ethmoid sinuses
|
32 ethmoid sinuses
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
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 \*
Outcome measures
| Measure |
Pilot 15 mm
n=38 ethmoid sinuses
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.
|
Efficacy 25 mm
n=38 ethmoid sinuses
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).
|
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.
|
|---|---|---|---|
|
Significant Adhesion Occurrence
|
2 ethmoid sinuses
|
8 ethmoid sinuses
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Pilot 15 mm
n=38 ethmoid sinuses
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.
|
Efficacy 25 mm
n=38 ethmoid sinuses
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).
|
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.
|
|---|---|---|---|
|
Polypoid Tissue Changes
|
7 ethmoid sinuses
|
14 ethmoid sinuses
|
—
|
Adverse Events
Pilot 15 mm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Efficacy 25 mm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Safety/PK 25 mm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place