S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
RESOLVE_II
A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Sinus Obstruction
1 other identifier
interventional
300
1 country
40
Brief Summary
The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2014
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2014
CompletedFirst Posted
Study publicly available on registry
November 14, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
July 9, 2018
CompletedAugust 15, 2018
July 1, 2018
1.8 years
November 11, 2014
April 16, 2018
July 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Nasal Obstruction/Congestion Score
Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms.
Day 30
Bilateral Polyp Grade
Polyp grade was determined by an independent panel of 3 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 indicated reduction (improvement) in bilateral polyp grade.
Day 90
Secondary Outcomes (5)
Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)
Day 90
Ethmoid Sinus Obstruction
Day 90
Nasal Obstruction/Congestion Score
Day 90
Decreased Sense of Smell Score
Day 90
Facial Pain/Pressure Score
Day 90
Study Arms (2)
Treatment
EXPERIMENTALIn-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 COMPARATORIn-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Interventions
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
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.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of chronic sinusitis
- 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
You may not qualify if:
- Patient has presence of polyposis grade 1, 1.5 or 4 on either side
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intersect ENTlead
Study Sites (40)
The University of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Kaiser Permanente Orange County Irvine Medical Center
Irvine, California, 92618, United States
Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc.
Sacramento, California, 95815, United States
Colorado ENT and Allergy
Colorado Springs, Colorado, 80909, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
GW Medical Facility Associates
Washington D.C., District of Columbia, 20037, United States
University of Miami
Miami, Florida, 33136, United States
South Florida ENT
Miami, Florida, 33176, United States
& Facial Plastic Surgery
Riverview, Florida, 33578, United States
ENT of Georgia
Atlanta, Georgia, 30342, United States
Northwestern Medical Faculty Foundation, Department of Otolaryngology
Chicago, Illinois, 60611, United States
DuPage Medical Group
Naperville, Illinois, 60540, United States
Iowa ENT Center
West Des Moines, Iowa, 50265, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Advanced ENT and Allergy
Louisville, Kentucky, 40207, United States
Associated Surgical Specialists
Covington, Louisiana, 70433, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Rontal Akervall Clinic
Royal Oak, Michigan, 48073, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Ear, Nose and Throat Consultants of Nevada
Las Vegas, Nevada, 89128, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
Breathe America/NM Sinus
Albuquerque, New Mexico, 87109, United States
Albany ENT & Allergy
Albany, New York, 12206, United States
Madison ENT & Facial Plastic Surgery
New York, New York, 10016, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Charlotte Eye, Ear, Nose and Throat Associates
Concord, North Carolina, 29025, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Bethlehem Ear, Nose and Throat Associates
Bethlehem, Pennsylvania, 18017, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
University of Texas
Houston, Texas, 77030, United States
Cache Valley ENT
North Logan, Utah, 84341, United States
Intermountain/ENT Center of UT
Salt Lake City, Utah, 84102, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
Reston ENT
Reston, Virginia, 20190, United States
Virginia ENT
Richmond, Virginia, 23233, United States
Medical College of Wisconsin - Greenway Clinic
Milwaukee, Wisconsin, 53227, United States
Related Publications (1)
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.
PMID: 29350840BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
1. The absence of a defined medical regimen prior to enrollment. 2. The clinical investigators performing assessment of indication for RESS at Day 90 were unblinded. 3. The relatively short duration of the trial (90 days).
Results Point of Contact
- Title
- James Stambaugh, Vice President of Clinical & Medical Affairs
- Organization
- Intersect ENT, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Robert C Kern, MD
Department of Otolaryngology, Northwestern University, Chicago, IL
- PRINCIPAL INVESTIGATOR
Jose P. Stolovitzky, MD
ENT of Georgia, Atlanta, GA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2014
First Posted
November 14, 2014
Study Start
December 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
August 15, 2018
Results First Posted
July 9, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share