Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps

NCT ID: NCT01732536

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-05-31

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.

Conditions

Chronic Sinusitis; Nasal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

S8 Sinus Implant

In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Mometasone furoate nasal spray (200mcg) once daily

Group Type: EXPERIMENTAL

S8 Sinus Implant

Intervention Type: DRUG

In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Mometasone furoate nasal spray

Intervention Type: DRUG

Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90

Control

In-office bilateral sham procedure

Mometasone furoate nasal spray (200mcg) once daily

Group Type: SHAM_COMPARATOR

Sham procedure

Intervention Type: PROCEDURE

In-office bilateral sham procedure

Mometasone furoate nasal spray

Intervention Type: DRUG

Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90

Interventions

S8 Sinus Implant

In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Intervention Type: DRUG

Sham procedure

In-office bilateral sham procedure

Intervention Type: PROCEDURE

Mometasone furoate nasal spray

Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90

Intervention Type: DRUG

Other Intervention Names

SINUVA (mometasone furoate) sinus implant; Nasonex Nasal Spray

Eligibility Criteria

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:

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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intersect ENT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith D Forwith, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced ENT and Allergy

Joseph K Han, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School Department of Otolaryngology

Locations

California Sinus Centers

Atherton, California, United States

Cedars-Sinai Medical Center, Sinus Center of Excellence

Los Angeles, California, United States

Sacramento Ear, Nose and Throat

Sacramento, California, United States

Colorado Ear, Nose, Throat & Allergy

Colorado Springs, Colorado, United States

South Florida ENT Associates

Miami, Florida, United States

ENT of Georgia

Atlanta, Georgia, United States

Northwestern University, Department of Otolaryngology-Head & Neck Surgery

Chicago, Illinois, United States

Advanced ENT & Allergy

Louisville, Kentucky, United States

Summit Medical Group

Berkeley Heights, New Jersey, United States

Albany ENT & Allergy Services

Albany, New York, United States

ENT and Allergy Associates

Lake Success, New York, United States

Piedmont Ear, Nose & Throat Associates

Winston-Salem, North Carolina, United States

Oregon Health and Science University-Dept. of Otolaryngology Head and Neck Surgery

Portland, Oregon, United States

Bethlehem ENT Specialty Physicians Associates

Bethlehem, Pennsylvania, United States

University of Pennsylvania, Dept of Otolaryngology-Head & Neck Surgery

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Intermountain Ear, Nose & Throat Center

Salt Lake City, Utah, United States

Eastern Virginia Medical School Department of Otolaryngology

Norfolk, Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25266981 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26992115 (View on PubMed)

Other Identifiers

P500-1012

Identifier Type: -

Identifier Source: org_study_id