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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00840970

Acronym

CONSENSUS II

Enrollment

Registered

2009-02-11

Start date

2008-03-31

Completion date

2009-04-30

Last updated

2020-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Sinusitis

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.

Interventions

DEVICEnon-coated Intranasal Splint

placement of non-coated intranasal splint following FESS

DEVICESinexus Intranasal Splint

placement of Sinexus Intranasal Splint placed following FESS

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention 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)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Device Success Rate	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.
Reduction in Ethmoid Sinus Inflammation	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

Measure	Time frame	Description
Middle Turbinate Lateralization	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.
Middle Meatus Patency	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).
Significant Adhesion Occurrence	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 \*
Polypoid Tissue Changes	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	50
Total	50

Arm

Count

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.

Total

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	0	0	1

Baseline characteristics

Characteristic	All Patients	—
Age, Continuous	47.1 years STANDARD_DEVIATION 15.5	—
History of smoking Current smoker	5 Participants	—
History of smoking Never smoked	40 Participants	—
History of smoking Previous smoker, stopped > 1 year ago	5 Participants	—
Lund-Mackay score Left	6.9 units on a scale STANDARD_DEVIATION 2.2	—
Lund-Mackay score Right	6.8 units on a scale STANDARD_DEVIATION 2.3	—
Lund-Mackay score Total	13.6 units on a scale STANDARD_DEVIATION 4.1	—
Number of prior sinus procedures 0	29 Participants	—
Number of prior sinus procedures 1	13 Participants	—
Number of prior sinus procedures 2	7 Participants	—
Number of prior sinus procedures 3	0 Participants	—
Number of prior sinus procedures >=4	1 Participants	—
Polyps	38 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	22 Participants	—
Sex: Female, Male Male	28 Participants	—
Symptoms pre-op Anosmia	15 Participants	—
Symptoms pre-op Cough	9 Participants	—
Symptoms pre-op Dental pain	3 Participants	—
Symptoms pre-op Discolored nasal discharge	11 Participants	—
Symptoms pre-op Ear pain, pressure, fullness	6 Participants	—
Symptoms pre-op Facial pain, pressure, other	20 Participants	—
Symptoms pre-op Fatigue	6 Participants	—
Symptoms pre-op Halitosis	3 Participants	—
Symptoms pre-op Headache	17 Participants	—
Symptoms pre-op Nasal obstruction/congestion	40 Participants	—
Symptoms pre-op Other	22 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 7	0 / 38	0 / 5
other Total, other adverse events	0 / 7	0 / 38	0 / 5
serious Total, serious adverse events	0 / 7	0 / 38	0 / 5

Outcome results

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.

Time frame: Baseline

Population: Analysis per patient.

Arm	Measure	Value (COUNT_OF_UNITS)
Pilot 15 mm	Device Success Rate	14 ethmoid sinuses
Efficacy 25 mm	Device Success Rate	76 ethmoid sinuses
Safety/PK 25 mm	Device Success Rate	10 ethmoid sinuses

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.

Time frame: 21 days