ClinicalTrials.gov
ClinicalTrials.gov Menu

Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps (RESOLVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01732536
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Intersect ENT

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

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Nasal Polyps Drug: S8 Sinus Implant Procedure: Sham procedure Drug: Mometasone furoate nasal spray Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants were blindfolded and earmuffed during the baseline procedure and follow-up endoscopic examinations. Implants were removed at Day 60 to allow blinded assessment of bilateral polyp grade at Day 90 by a centralized videoendoscopy review by a panel of 3 independent sinus surgeons.
Primary Purpose: Treatment
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
Actual Study Start Date : January 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Experimental: 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

Drug: S8 Sinus Implant
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Other Name: SINUVA (mometasone furoate) sinus implant

Drug: Mometasone furoate nasal spray
Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90
Other Name: Nasonex Nasal Spray

Sham Comparator: Control

In-office bilateral sham procedure

Mometasone furoate nasal spray (200mcg) once daily

Procedure: Sham procedure
In-office bilateral sham procedure

Drug: Mometasone furoate nasal spray
Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90
Other Name: Nasonex Nasal Spray




Primary Outcome Measures :
  1. Nasal Obstruction/Congestion Score [ Time Frame: 90 days ]
    Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in

  2. Bilateral Polyp Grade [ Time Frame: 90 days ]
    Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction (improvement) in bilateral polyp grade.


Secondary Outcome Measures :
  1. Ethmoid Sinus Obstruction [ Time Frame: 90 days ]
    Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline represented reduction (improvement) in ethmoid sinus obstruction.

  2. Bilateral Polyp Grade [ Time Frame: 90 days, 6 months ]
    Polyps were graded by clinical investigators on a scale from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicate reduction (improvement) in nasal polyps.

  3. Nasal Obstruction Symptom Evaluation (NOSE) Score [ Time Frame: 6 months ]
    NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score.

  4. Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS) [ Time Frame: 90 days, 6 months ]

    To be indicated for RESS, the following criteria had to be met:

    • Continued to use topical intranasal steroids daily;
    • Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use
    • Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and
    • Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade >=2 on at least one side)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732536


Locations
United States, California
California Sinus Centers
Atherton, California, United States, 94027
Cedars-Sinai Medical Center, Sinus Center of Excellence
Los Angeles, California, United States, 90048
Sacramento Ear, Nose and Throat
Sacramento, California, United States, 95815
United States, Colorado
Colorado Ear, Nose, Throat & Allergy
Colorado Springs, Colorado, United States, 80909
United States, Florida
South Florida ENT Associates
Miami, Florida, United States, 33176
United States, Georgia
ENT of Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern University, Department of Otolaryngology-Head & Neck Surgery
Chicago, Illinois, United States, 60611
United States, Kentucky
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40207
United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 07922
United States, New York
Albany ENT & Allergy Services
Albany, New York, United States, 12206
ENT and Allergy Associates
Lake Success, New York, United States, 11042
United States, North Carolina
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Oregon Health and Science University-Dept. of Otolaryngology Head and Neck Surgery
Portland, Oregon, United States, 97239
United States, Pennsylvania
Bethlehem ENT Specialty Physicians Associates
Bethlehem, Pennsylvania, United States, 18017
University of Pennsylvania, Dept of Otolaryngology-Head & Neck Surgery
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Utah
Intermountain Ear, Nose & Throat Center
Salt Lake City, Utah, United States, 84102
United States, Virginia
Eastern Virginia Medical School Department of Otolaryngology
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53266
Sponsors and Collaborators
Intersect ENT
Investigators
Principal Investigator: Keith D Forwith, MD Advanced ENT and Allergy
Principal Investigator: Joseph K Han, MD Eastern Virginia Medical School Department of Otolaryngology

Publications of Results:
Other Publications:
Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT01732536     History of Changes
Other Study ID Numbers: P500-1012
First Posted: November 26, 2012    Key Record Dates
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Intersect ENT:
corticosteroid-eluting sinus implant
chronic rhinosinusitis
mometasone furoate
polyposis

Additional relevant MeSH terms:
Polyps
Sinusitis
Nasal Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents