A Clinical Evaluation of PROPEL® Contour Sinus Implant

Completed · Not applicable

Conditions studied: Chronic Rhinosinusitis (Diagnosis)

In brief

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)

Key facts

Study ID

NCT04858802

Run by

Intersect ENT

People needed

80

Starts

2021-05-12

Expected to finish

2022-06-20

Last updated by the study team

2023-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Sacramento ENT/DaVinci Research, LLC — Sacramento, California, United States
• San Francisco Otolaryngology — San Francisco, California, United States
• ENT & Allergy Associate of Florida, LLC — Boca Raton, Florida, United States
• ENT & Allergy Associate of Florida, LLC — Boynton Beach, Florida, United States
• ENT of Georgia — Atlanta, Georgia, United States
• Ascentist Physicians Group — Leawood, Kansas, United States
• Kentuckiana Ear, Nose & Throat PSC — Louisville, Kentucky, United States
• Advanced ENT & Allergy — Louisville, Kentucky, United States
• Madison ENT — New York, New York, United States
• Ohio Sinus Institute — Dublin, Ohio, United States
• Fort Worth ENT & Sinus — Fort Worth, Texas, United States
• Collin County ENT — Frisco, Texas, United States
• ENT Associates of Texas — McKinney, Texas, United States
• Alamo ENT Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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