CompletedNot Applicable

A Clinical Evaluation of PROPEL® Contour Sinus Implant

United States80 participantsStarted 2021-05-12

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Difference in FSO Patency by Blinded Reviewer

Timeframe: Day 45

Trial details

NCT IDNCT04858802

SponsorIntersect ENT

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-10

Results submitted2023-02-07

View on ClinicalTrials.gov More Chronic Rhinosinusitis (Diagnosis) trials