- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04858802
A Clinical Evaluation of PROPEL® Contour Sinus Implant (EXPAND)
The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95815
- Sacramento ENT/DaVinci Research, LLC
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San Francisco, California, United States, 94108
- San Francisco Otolaryngology
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Florida
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Boca Raton, Florida, United States, 33487
- ENT & Allergy Associate of Florida, LLC
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Boynton Beach, Florida, United States, 33426
- ENT & Allergy Associate of Florida, LLC
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Georgia
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Atlanta, Georgia, United States, 30342
- ENT of Georgia
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Kansas
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Leawood, Kansas, United States, 66211
- Ascentist Physicians Group
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Kentucky
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Louisville, Kentucky, United States, 40220
- Advanced ENT & Allergy
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Louisville, Kentucky, United States, 40205
- Kentuckiana Ear, Nose & Throat PSC
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New York
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New York, New York, United States, 10016
- Madison ENT
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Ohio
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Dublin, Ohio, United States, 43016
- Ohio Sinus Institute
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Texas
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Fort Worth, Texas, United States, 76109
- Fort Worth ENT & Sinus
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Frisco, Texas, United States, 75034
- Collin County ENT
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McKinney, Texas, United States, 75070
- ENT Associates of Texas
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San Antonio, Texas, United States, 78258
- Alamo ENT Associates
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient is 18 years of age or older.
- Patient is willing and able to comply with protocol requirements.
- Patient has confirmed diagnosis of CRS per International Consensus Statement on Allergy and Rhinology, Rhinosinusitis 2021 (ICAR:RS) guidelines.
- 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.
- 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:
- Patient has structural obstruction that precludes endoscopic visualization of one or both FSOs prior to implant placement.
- Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade > 2) unless reduced 30 days prior to the baseline procedure
- Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
- Known history of allergy or intolerance to corticosteroids or mometasone furoate.
- Patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers.
- 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.
- Patients with monopolar pacemakers (older designs, with lower resistance to interference) or ICD's (implantable cardioverter defibrillator).
- Patients with implantable, body worn devices such as insulin pumps.
- Evidence of purulence coming from paranasal sinuses or ostiomeatal complex.
- Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior CT scan, necrotic sinus tissue).
- Active viral illness (e.g., flu, shingles).
- Use of parenteral or injected steroids (e.g. Kenalog) 30 days prior to the baseline procedure.
- Use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PROPEL Contour Sinus Implant
Following successful in-office bilateral balloon dilation, placement of PROPEL Contour Sinus Implant in the randomized side.
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370 mcg mometasone furoate-coated sinus implant
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Active Comparator: Balloon Sinus Dilation Alone
Following successful in-office bilateral balloon dilation, placement of no implant on the contralateral side.
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No PROPEL Contour Sinus Implant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in FSO Patency by Blinded Reviewer
Time Frame: Day 45
|
Side-to-side difference in frontal sinus ostium (FSO) patency at Day 45 based on cross-sectional area of FSO by computed tomography (CT) measurements performed by an independent, blinded reviewer.
Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.
|
Day 45
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FSO Cross-sectional Area Change From Baseline on CT by an Independent, Blinded Reviewer
Time Frame: Baseline, Day 45, and Day 180
|
FSO cross-sectional area change from baseline to Day 45 and change from baseline to Day 180 per CT assessment performed by an independent, blinded reviewer.
FSO cross-sectional area was measured via computer-assisted segmentation of CT images.
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Baseline, Day 45, and Day 180
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CT Frontal Sinus Outflow Tract (FSOT) Volume by Blinded Reviewer
Time Frame: Days 45 and 180
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FSOT, referring to the region of the frontal sinus surrounding the FSO, bordered superiorly by the frontal infundibulum and inferiorly by the frontal recess, is assessed by blinded reviewer.
FSOT volume was measured via computer-assisted segmentation of CT images.
|
Days 45 and 180
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CT FSO Minimum Diameter by Blinded Reviewer
Time Frame: Days 45 and 180
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CT FSO minimum diameter assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.
FSO minimum diameter was measured via computer-assisted segmentation of CT images.
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Days 45 and 180
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CT Zinreich's Modified Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
Time Frame: Days 45 and 180
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CT Zinreich's modified Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. Zinreich's modified Lund-Mackay scale ranges from 0 to 5. Higher scores indicate a worse outcome. |
Days 45 and 180
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Number of Sinus Sides Requiring Post-operative Intervention by Clinical Investigators
Time Frame: Days 21, 45, 90 and 180
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Need for post-operative intervention as determined by clinical investigators per endoscopy.
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Days 21, 45, 90 and 180
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CT Cross-sectional Area of FSO by Blinded Reviewer
Time Frame: Day 180
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CT cross-sectional area of FSO assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses.
Cross-sectional area of FSO was measured via computer-assisted segmentation of CT images.
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Day 180
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CT Lund-Mackay Score for the Frontal Sinus by Blinded Reviewer
Time Frame: Days 45 and 180
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CT Lund-Mackay score for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome. |
Days 45 and 180
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CT Lund-Mackay Score for the Frontal Sinus by Clinical Investigators
Time Frame: Days 45 and 180
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CT Lund-Mackay for the frontal sinus assessed by blinded independent reviewer to assess extent of the disease in the frontal sinuses. The Lund-Mackay scale ranges from 0 to 2. Higher scores indicate a worse outcome. |
Days 45 and 180
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Adhesion/Scarring Grade in the Frontal Recess/FSO by Clinical Investigators
Time Frame: Days 21, 45, 90 and 180
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Endoscopic grading of adhesion/scarring grade in the frontal recess/FSO by clinical investigators. The adhesion/scarring grade in the frontal recess/FSO scale ranges from 0 to 4. Higher scores indicate a worse outcome. |
Days 21, 45, 90 and 180
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Inflammation Score in the Frontal Recess/FSO by Clinical Investigators
Time Frame: Days 21, 45, 90 and 180
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Endoscopic grading of inflammation score in the frontal recess/FSO by clinical investigators. Inflammation score in the frontal recess/FSO ranges from 0 to 100. Higher scores indicate a worse outcome. |
Days 21, 45, 90 and 180
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Polypoid Edema in the Frontal Recess/FSO by Clinical Investigators
Time Frame: Days 21, 45, 90 and 180
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Endoscopic grading of polypoid edema in the frontal recess/FSO by clinical investigators. Polypoid edema in the frontal recess/FSO scale ranges from 0 to 3. Higher scores indicate a worse outcome. |
Days 21, 45, 90 and 180
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Adhesion/Scarring Grade in the Ethmoid Sinus by Clinical Investigators
Time Frame: Day 21, 45, 90, and 180
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Endoscopic grading of adhesion/scarring grade in the ethmoid sinus by clinical investigators. The adhesion/scarring grade in the ethmoid sinus scale ranges from 0 to 4. Higher scores indicate a worse outcome. |
Day 21, 45, 90, and 180
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Polyp Grade in the Ethmoid Sinus by Clinical Investigators
Time Frame: Days 21, 45, 90 and 180
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Endoscopic grading of polyp grade in the ethmoid sinus by clinical investigators. Polyp grade in the ethmoid sinus scale ranges from 0 to 3. Higher scores indicate a worse outcome. |
Days 21, 45, 90 and 180
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CRS Side-specific Symptom Score by Subject
Time Frame: Days 21, 45, 90 and 180
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Subject-reported outcome of chronic rhinosinusitis (CRS) side-specific symptom score. The chronic rhinosinusitis side-specific symptom score scale ranges from 0 to 30. Higher scores indicate a worse outcome. |
Days 21, 45, 90 and 180
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SNOT-22 Score by Subject
Time Frame: Day 180
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Subject-reported outcome of SNOT-22 score. The Sino-Nasal Outcome Test, 22 item (SNOT-22) is a validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a 6-point scale, ranging from a score of 0 ("no problem") to 5 ("problem as bad as it can be"). The maximum total score for all symptoms is equal to 110. Higher scores indicate a worse outcome. |
Day 180
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RSI Score by Subject
Time Frame: Day 180
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Subject-reported outcome of RSI score. The Rhinosinusitis Symptom Inventory (RSI) scale ranges from 0 to 60. Higher scores indicate a worse outcome. |
Day 180
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Implant Delivery Success by Clinical Investigators
Time Frame: Baseline
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Number of subjects who underwent successful access and deployment of the PROPEL Contour Sinus Implant into the FSO.
Delivery is considered successful if the procedure concludes with correct implant placement on the intended side, even if a second attempt to place the implant is necessary.
An attempted deployment occurs when the investigator introduces the delivery system into the subject's nostril with the intent of placing an implant.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P500-1220
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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