Clinical trial NCT01732536: Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
Official title: A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients With Recurrent Sinus Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Sinusitis
Nasal Polyps
Keywords: corticosteroid-eluting sinus implant
chronic rhinosinusitis
mometasone furoate
polyposis
Lead sponsor: Intersect ENT
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.

Detailed description: RESOLVE is a randomized (1:1), sham-controlled, parallel group, double-blind multicenter study in 100 chronic sinusitis patients who had prior endoscopic sinus surgery and presented with recurrent nasal polyps. The objective of the study was to assess the safety and efficacy of the S8 Sinus Implant, a steroid-eluting sinus implant, consisting of a bioabsorbable self-expanding sinus implant coated with 1350 mcg of mometasone furoate (MF) and a single-use delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The coating on the S8 implant provides controlled release of MF to the sinus mucosa over 90 days, with the majority of drug released within 60 days.

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.

Primary outcomes:
measure: Nasal Obstruction/Congestion Score
timeFrame: 90 days
measure: Bilateral Polyp Grade
timeFrame: 90 days
Secondary outcomes:
measure: Ethmoid Sinus Obstruction
timeFrame: 90 days
measure: Bilateral Polyp Grade
timeFrame: 90 days, 6 months
measure: Nasal Obstruction Symptom Evaluation (NOSE) Score
timeFrame: 6 months
measure: Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)
timeFrame: 90 days, 6 months
Other outcomes:
Locations:
city: Atherton
country: United States
facility: California Sinus Centers
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Sinus Center of Excellence
state: California
city: Sacramento
country: United States
facility: Sacramento Ear, Nose and Throat
state: California
city: Colorado Springs
country: United States
facility: Colorado Ear, Nose, Throat & Allergy
state: Colorado
city: Miami
country: United States
facility: South Florida ENT Associates
state: Florida
city: Atlanta
country: United States
facility: ENT of Georgia
state: Georgia
city: Chicago
country: United States
facility: Northwestern University, Department of Otolaryngology-Head & Neck Surgery
state: Illinois
city: Louisville
country: United States
facility: Advanced ENT & Allergy
state: Kentucky
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Albany
country: United States
facility: Albany ENT & Allergy Services
state: New York
city: Lake Success
country: United States
facility: ENT and Allergy Associates
state: New York
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose & Throat Associates
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University-Dept. of Otolaryngology Head and Neck Surgery
state: Oregon
city: Bethlehem
country: United States
facility: Bethlehem ENT Specialty Physicians Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania, Dept of Otolaryngology-Head & Neck Surgery
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Salt Lake City
country: United States
facility: Intermountain Ear, Nose & Throat Center
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School Department of Otolaryngology
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Advanced ENT and Allergy
name: Keith D Forwith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Virginia Medical School Department of Otolaryngology
name: Joseph K Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han JK, Forwith KD, Smith TL, Kern RC, Brown WJ, Miller SK, Ow RA, Poetker DM, Karanfilov B, Matheny KE, Stambaugh J, Gawlicka AK. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014 Nov;4(11):861-70. doi: 10.1002/alr.21426. Epub 2014 Sep 29.
citation: Forwith KD, Han JK, Stolovitzky JP, Yen DM, Chandra RK, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016 Jun;6(6):573-81. doi: 10.1002/alr.21741. Epub 2016 Mar 14.