Clinical trial NCT04858802: A Clinical Evaluation of PROPEL® Contour Sinus Implant
Official title: The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Keywords: Frontal Sinus
Balloon Dilation
Lead sponsor: Intersect ENT
Sponsor class: INDUSTRY
First posted: 2021-04-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intrapatient control in which eligible subjects will receive the PROPEL Contour Sinus Implant (Treatment) on one side, and no implant (Control) on the contralateral side.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)

Detailed description: A post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 study centers.

After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure™ Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the control.

Eligibility criteria: Inclusion Criteria:

1. Patient is 18 years of age or older.
2. Patient is willing and able to comply with protocol requirements.
3. Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and Rhinology, Rhinosinusitis 2021 (ICAR:RS) guidelines.
4. Bilateral disease in the frontal sinuses (Lund-Mackay CT score of ≥1 on each side) on CT scan within 90 days prior to the baseline.
5. A successfully completed in-office bilateral balloon dilation of the FSO with no complication on either side that, in the opinion of the clinical investigator is amenable for PROPEL Contour Sinus Implant placement in both FSO

Exclusion Criteria:

1. Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs prior to implant placement.
2. Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade \> 2) unless reduced 30 days prior to the baseline procedure
3. Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
4. Known history of allergy or intolerance to corticosteroids or mometasone furoate.
5. Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers.
6. Patients with electronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators (e.g. deep brain stimulation), programmable cerebrospinal fluid (CSF) shunts.
7. Patients with monopolar pacemakers (older designs, with lower resistance to interference) or ICD's (implantable cardioverter defibrillator).
8. Patients with implantable, body worn devices such as insulin pumps.
9. Evidence of purulence coming from paranasal sinuses or ostiomeatal complex.
10. Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue).
11. Active viral illness (e.g., flu, shingles).
12. Use of parenteral or injected steroids (e.g. Kenalog) 30 days prior to the baseline procedure.
13. Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure.

Primary outcomes:
measure: Difference in FSO Patency by Blinded Reviewer
timeFrame: Day 45
Secondary outcomes:
measure: FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer
timeFrame: Baseline, Day 45, and Day 180
measure: CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer
timeFrame: Days 45 and 180
measure: CT FSO Minimum Diameter by Blinded Reviewer
timeFrame: Days 45 and 180
measure: CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
timeFrame: Days 45 and 180
measure: Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators
timeFrame: Days 21, 45, 90 and 180
measure: CT Cross-sectional Area of FSO by Blinded Reviewer
timeFrame: Day 180
measure: CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
timeFrame: Days 45 and 180
measure: CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators
timeFrame: Days 45 and 180
measure: Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators
timeFrame: Days 21, 45, 90 and 180
measure: Inflammation Score in the Frontal Recess/FSO by Clinical Investigators
timeFrame: Days 21, 45, 90 and 180
measure: Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators
timeFrame: Days 21, 45, 90 and 180
measure: Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators
timeFrame: Day 21, 45, 90, and 180
measure: Polyp Grade in the Ethmoid Sinus by Clinical Investigators
timeFrame: Days 21, 45, 90 and 180
measure: CRS Side-specific Symptom Score by Subject
timeFrame: Days 21, 45, 90 and 180
measure: SNOT-22 Score by Subject
timeFrame: Day 180
measure: RSI Score by Subject
timeFrame: Day 180
measure: Implant Delivery Success by Clinical Investigators
timeFrame: Baseline
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sacramento ENT/DaVinci Research, LLC
state: California
city: San Francisco
country: United States
facility: San Francisco Otolaryngology
state: California
city: Boca Raton
country: United States
facility: ENT & Allergy Associate of Florida, LLC
state: Florida
city: Boynton Beach
country: United States
facility: ENT & Allergy Associate of Florida, LLC
state: Florida
city: Atlanta
country: United States
facility: ENT of Georgia
state: Georgia
city: Leawood
country: United States
facility: Ascentist Physicians Group
state: Kansas
city: Louisville
country: United States
facility: Kentuckiana Ear, Nose & Throat PSC
state: Kentucky
city: Louisville
country: United States
facility: Advanced ENT & Allergy
state: Kentucky
city: New York
country: United States
facility: Madison ENT
state: New York
city: Dublin
country: United States
facility: Ohio Sinus Institute
state: Ohio
city: Fort Worth
country: United States
facility: Fort Worth ENT & Sinus
state: Texas
city: Frisco
country: United States
facility: Collin County ENT
state: Texas
city: McKinney
country: United States
facility: ENT Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: Alamo ENT Associates
state: Texas
Study officials:
References: