Status:
COMPLETED
A Clinical Evaluation of PROPEL® Contour Sinus Implant
Lead Sponsor:
Intersect ENT
Conditions:
Chronic Rhinosinusitis (Diagnosis)
Eligibility:
All Genders
18+ years
Phase:
NA
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 fron...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04858802
Start Date
May 12 2021
End Date
June 20 2022
Last Update
April 21 2023
Active Locations (14)
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1
Sacramento ENT/DaVinci Research, LLC
Sacramento, California, United States, 95815
2
San Francisco Otolaryngology
San Francisco, California, United States, 94108
3
ENT & Allergy Associate of Florida, LLC
Boca Raton, Florida, United States, 33487
4
ENT & Allergy Associate of Florida, LLC
Boynton Beach, Florida, United States, 33426