Clinical trial NCT01732536 (phase 2/phase 3, status: completed)
Conditions: chronic sinusitis, nasal polyps
ICD codes: J32.0, J32.1, J32.2, J32.3, J32.8, J32.9
Drugs: s8 sinus implant, mometasone furoate nasal spray
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C
Eligibility criteria:

        Inclusion Criteria

        Candidates for this study had to meet ALL of the following inclusion criteria:

        1. General Inclusion Criteria

          1. Patient has provided written informed consent using a form approved by the reviewing
             IRB.

          2. Patient is ≥ 18 years of age.

          3. Patient is willing and able to comply with protocol requirements.

          4. Patient has a previous confirmed diagnosis of CS defined as inflammation of the mucosa
             of the paranasal sinuses.

          5. Patient has undergone bilateral total ethmoidectomy (must be at least 90 day beyond
             the date of last sinus surgery).

          6. Patient has recurrent bilateral sinus obstruction due to polyposis (Grades 1 through 3
             only).

          7. Patient must have a Grade 2 polyposis on at least 1 ethmoid side.

          8. Patient is able to tolerate the use of Nasonex topical intranasal steroid spray once
             daily.

          9. Patient is indicated for a repeat ESS per the study definition. Patient must have: (i)
             a minimum symptom burden on the SNOT 22, consisting of a minimum score of 2 on at
             least 2 of the 5 hallmark symptoms of CS (nasal blockage, post-nasal discharge, thick
             nasal discharge, facial pain/pressure, and decreased sense of smell); (ii) persistent
             symptoms of CS despite ongoing treatment with topical intranasal steroid irrigations
             or sprays at least once daily for at least 2 weeks preceding enrollment; (iii) had
             treatment with a high-dose form of steroids (e.g., oral, parenteral, injection into
             polyps) and/or sinus steroid irrigations within the preceding 2 years, or refused such
             therapy due to intolerance/side effects; (iv) a known history of repeated courses of
             treatment with aggressive steroid therapy for recurrent sinusitis; and (v) endoscopic
             evidence of polyp recurrence, scarring, and/or obstructive mucosal edema.

         10. Patient is able to tolerate use of topical/local anesthesia and the implant procedure
             in an office or clinic setting.

         11. In the opinion of the physician, treatment with S8 Sinus Implant or sham procedure is
             technically feasible (able to pass 5-9 mm device into middle meatus) bilaterally.

         12. Female patients of child-bearing potential must not be pregnant and must agree to not
             become pregnant during the course of the study.

         13. Female patients of child-bearing potential must agree to use consistent and acceptable
             method/s of birth control during the course of the study.

        Exclusion Criteria

        Candidates were excluded if they met ANY of the following criteria:

        General Exclusion Criteria

          1. Patient had bilateral total ethmoidectomy less than 90 days previously.

          2. Patient had Propel implanted postoperatively less than 90 days previously.

          3. Patient has presence of adhesions/synechiae Grades 3 or 4.

          4. Patient has presence of severe scarring or adhesions within the ethmoid cavity itself.

          5. Patient has presence of Grade 4 polyposis.

          6. Patient has known history of immune deficiency (e.g., IGG] subclass deficiency or IGA
             deficiency, HIV).

          7. Patient has concurrent condition requiring active chemotherapy and/or immunotherapy
             management for the disease (e.g., cancer, HIV, etc.).

          8. Patient has oral-steroid dependent condition such as chronic obstructive pulmonary
             disease (COPD), asthma or other condition.

          9. Patient has known history of allergy or intolerance to corticosteroids or mometasone
             furoate (MF).

         10. Patient has known history of resistance or poor response to oral steroids.

         11. Patient has presence of physical obstruction that would preclude access to either
             ethmoid sinus for device delivery (e.g., severe septal deviation, septal spur, very
             small middle meatus, total obstruction of the nasal passage with severe scarring,
             polyposis).

         12. Patient has clinical evidence of acute bacterial sinusitis (e.g., acute increase in
             purulent discharge, fever, facial pain etc.).

         13. Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone
             erosion on prior CT scan, necrotic sinus tissue, etc.).

         14. Patient has evidence of disease or condition expected to compromise survival or
             ability to complete follow-up assessments during the 6 month follow-up period.

         15. Patient is currently participating in or recently participated in another clinical
             trial (within the last 30 days).

         16. Patient has history of insulin dependent diabetes mellitus.

         17. Patient has previously undergone ESS and experienced a CSF leak or has residual
             compromised vision as a result of a complication in a prior ESS procedure.

         18. Patient has completely resected middle turbinate.

         19. Patient has known dehiscence of the lamina papyracea.

         20. Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes
             simplex, chickenpox, or measles).

             Ocular Exclusion Criteria

         21. Patient has history or diagnosis of glaucoma or ocular hypertension (baseline or a
             known prior ocular exam indicating IOP >21 mm Hg)

         22. Patient has closed angle (with or without the presence of peripheral anterior
             synechiae on gonioscopy)

         23. Patient has presence in either eye of: (i) posterior subcapsular cataract, (ii)
             nuclear sclerosis of Grade +3 or higher; or (iii) cortical cataract of Grade +3 or
             higher.