S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
NCT ID: NCT02291549
Last Updated: 2018-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2014-12-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
S8 Sinus Implant
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray
Mometasone furoate nasal spray (200mcg) once daily
Control
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
Mometasone furoate nasal spray
Mometasone furoate nasal spray (200mcg) once daily
Sham
In-office bilateral sham procedure, consisting of advancement of a delivery system with the S8 Sinus Implant into the ethmoid sinuses followed by removal without deployment.
Interventions
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S8 Sinus Implant
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray
Mometasone furoate nasal spray (200mcg) once daily
Sham
In-office bilateral sham procedure, consisting of advancement of a delivery system with the S8 Sinus Implant into the ethmoid sinuses followed by removal without deployment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has undergone bilateral total ethmoidectomy at least 90 days prior to screening
* Patient has Nasal Obstruction/Congestion score of at least 2 (scale from 0 to 3) on at least 5 days during the 7 days following informed consent, despite use of topical intranasal steroid irrigations or sprays for at least 14 days preceding scoring, as documented in medication records
* Indication for repeat ESS:
* Complaints of at least 2 symptoms of chronic sinusitis: nasal obstruction/congestion, post-nasal discharge, thick nasal discharge, facial pain/pressure, or decreased sense of smell
* Endoscopic evidence of bilateral sinus obstruction due to polyposis (minimum grade 2 on each side)
* History of high-dose steroid use and/or sinus steroid irrigations within the preceding 1 year
Exclusion Criteria
* Patient has presence of adhesions/synechiae grades 3 or 4
* Patient has known history of immune deficiency
* Patient has concurrent condition such as cancer or HIV requiring active chemotherapy and/or immunotherapy management for the disease
* Patient has oral-steroid dependent condition such as COPD, asthma or other condition
* Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate
* Patient has presence of physical obstruction that would preclude access to either ethmoid sinus for implant delivery (e.g., severe septal deviation, septal spur, very small middle meatus, total obstruction of the nasal passage with severe scarring, polyposis)
* Patient has clinical evidence of acute bacterial sinusitis
* Patient has clinical evidence or suspicion of invasive fungal sinusitis
* Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day follow-up period
* Patient is currently participating in another clinical trial or has already participated in this clinical trial
* Patient has history of insulin dependent diabetes mellitus
* Patient has previously undergone ESS and experienced a cerebrospinal fluid (CSF) leak or has residual compromised vision as a result of a complication in a prior ESS procedure
* Patient has known dehiscence of the lamina papyracea
* Patient has evidence of active viral illness
* Patient has known history or diagnosis of glaucoma or ocular hypertension (prior ocular exam with IOP\>21 mm Hg and pressure lowering medication given) or posterior subcapsular cataract
18 Years
ALL
No
Sponsors
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Intersect ENT
INDUSTRY
Responsible Party
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Principal Investigators
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Robert C Kern, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Otolaryngology, Northwestern University, Chicago, IL
Jose P. Stolovitzky, MD
Role: PRINCIPAL_INVESTIGATOR
ENT of Georgia, Atlanta, GA
Locations
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The University of Alabama Birmingham
Birmingham, Alabama, United States
Kaiser Permanente Orange County Irvine Medical Center
Irvine, California, United States
Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc.
Sacramento, California, United States
Colorado ENT and Allergy
Colorado Springs, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
GW Medical Facility Associates
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
South Florida ENT
Miami, Florida, United States
& Facial Plastic Surgery
Riverview, Florida, United States
ENT of Georgia
Atlanta, Georgia, United States
Northwestern Medical Faculty Foundation, Department of Otolaryngology
Chicago, Illinois, United States
DuPage Medical Group
Naperville, Illinois, United States
Iowa ENT Center
West Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
Associated Surgical Specialists
Covington, Louisiana, United States
Johns Hopkins
Baltimore, Maryland, United States
Rontal Akervall Clinic
Royal Oak, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ear, Nose and Throat Consultants of Nevada
Las Vegas, Nevada, United States
Summit Medical Group
Berkeley Heights, New Jersey, United States
Breathe America/NM Sinus
Albuquerque, New Mexico, United States
Albany ENT & Allergy
Albany, New York, United States
Madison ENT & Facial Plastic Surgery
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Charlotte Eye, Ear, Nose and Throat Associates
Concord, North Carolina, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Bethlehem Ear, Nose and Throat Associates
Bethlehem, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas
Houston, Texas, United States
Cache Valley ENT
North Logan, Utah, United States
Intermountain/ENT Center of UT
Salt Lake City, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Reston ENT
Reston, Virginia, United States
Virginia ENT
Richmond, Virginia, United States
Medical College of Wisconsin - Greenway Clinic
Milwaukee, Wisconsin, United States
Countries
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References
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Kern RC, Stolovitzky JP, Silvers SL, Singh A, Lee JT, Yen DM, Iloreta AMC Jr, Langford FPJ, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK; RESOLVE II study investigators. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol. 2018 Apr;8(4):471-481. doi: 10.1002/alr.22084. Epub 2018 Jan 19.
Other Identifiers
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P500-1113
Identifier Type: -
Identifier Source: org_study_id
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