Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT04858802
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04858802
Study Brief:
Protocol Section:
NCT04858802