Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
- Conditions
- Chronic SinusitisNasal Polyps
- Interventions
- Registration Number
- NCT01732536
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S8 Sinus Implant Mometasone furoate nasal spray In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily Control Mometasone furoate nasal spray In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily S8 Sinus Implant 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 Control Sham procedure In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
- Primary Outcome Measures
Name Time Method Nasal Obstruction/Congestion Score 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
Bilateral Polyp Grade 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
Name Time Method Ethmoid Sinus Obstruction 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.
Bilateral Polyp Grade 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.
Nasal Obstruction Symptom Evaluation (NOSE) Score 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.
Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS) 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)
Trial Locations
- Locations (19)
South Florida ENT Associates
🇺🇸Miami, Florida, United States
Intermountain Ear, Nose & Throat Center
🇺🇸Salt Lake City, Utah, United States
Summit Medical Group
🇺🇸Berkeley Heights, New Jersey, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Oregon Health and Science University-Dept. of Otolaryngology Head and Neck Surgery
🇺🇸Portland, Oregon, United States
Cedars-Sinai Medical Center, Sinus Center of Excellence
🇺🇸Los Angeles, California, United States
ENT and Allergy Associates
🇺🇸Lake Success, New York, United States
California Sinus Centers
🇺🇸Atherton, California, United States
Colorado Ear, Nose, Throat & Allergy
🇺🇸Colorado Springs, Colorado, United States
Sacramento Ear, Nose and Throat
🇺🇸Sacramento, California, 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
Albany ENT & Allergy Services
🇺🇸Albany, New York, United States
Piedmont Ear, Nose & Throat Associates
🇺🇸Winston-Salem, North Carolina, United States
Bethlehem ENT Specialty Physicians Associates
🇺🇸Bethlehem, Pennsylvania, United States
University of Pennsylvania, Dept of Otolaryngology-Head & Neck Surgery
🇺🇸Philadelphia, Pennsylvania, United States
Eastern Virginia Medical School Department of Otolaryngology
🇺🇸Norfolk, Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States