The purpose of the study is to determine whether a steroid-eluting sinus implant is effective
in improving chronic sinusitis symptoms in patients who experience recurrent blockage of the
sinuses by polyps sometime after sinus surgery.
Drug: S8 Sinus Implant
Procedure: Sham procedure
Drug: Mometasone furoate nasal spray
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01732536
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Inclusion Criteria Candidates for this study had to meet ALL of the following
General Inclusion Criteria
Patient has provided written informed consent using a form approved by the reviewing IRB.
Patient is ≥ 18 years of age.
Patient is willing and able to comply with protocol requirements.
Patient has a previous confirmed diagnosis of CS defined as inflammation of the mucosa of the paranasal sinuses.
Patient has undergone bilateral total ethmoidectomy (must be at least 90 day beyond the date of last sinus surgery).
Patient has recurrent bilateral sinus obstruction due to polyposis (Grades 1 through 3 only).
Patient must have a Grade 2 polyposis on at least 1 ethmoid side.
Patient is able to tolerate the use of Nasonex topical intranasal steroid spray once daily.
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.
Patient is able to tolerate use of topical/local anesthesia and the implant procedure in an office or clinic setting.
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.
Female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study.
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
Patient had bilateral total ethmoidectomy less than 90 days previously.
Patient had Propel implanted postoperatively less than 90 days previously.
Patient has presence of adhesions/synechiae Grades 3 or 4.
Patient has presence of severe scarring or adhesions within the ethmoid cavity itself.
Patient has presence of Grade 4 polyposis.
Patient has known history of immune deficiency (e.g., IGG] subclass deficiency or IGA deficiency, HIV).
Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.).
Patient has oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD), asthma or other condition.
Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate (MF).
Patient has known history of resistance or poor response to oral steroids.
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).
Patient has clinical evidence of acute bacterial sinusitis (e.g., acute increase in purulent discharge, fever, facial pain etc.).
Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on prior CT scan, necrotic sinus tissue, etc.).
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.
Patient is currently participating in or recently participated in another clinical trial (within the last 30 days).
Patient has history of insulin dependent diabetes mellitus.
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.
Patient has completely resected middle turbinate.
Patient has known dehiscence of the lamina papyracea.
Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes simplex, chickenpox, or measles). Ocular Exclusion Criteria
Patient has history or diagnosis of glaucoma or ocular hypertension (baseline or a known prior ocular exam indicating IOP >21 mm Hg)
Patient has closed angle (with or without the presence of peripheral anterior synechiae on gonioscopy)
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.
All locations for NCT01732536
United States (19)
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
Colorado Ear, Nose, Throat & Allergy
Colorado Springs, Colorado, United States, 80909
South Florida ENT Associates
Miami, Florida, United States, 33176
ENT of Georgia
Atlanta, Georgia, United States, 30342
Northwestern University, Department of Otolaryngology-Head & Neck Surgery
Chicago, Illinois, United States, 60611
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40207
Summit Medical Group
Berkeley Heights, New Jersey, United States, 07922
Albany ENT & Allergy Services
Albany, New York, United States, 12206
ENT and Allergy Associates
Lake Success, New York, United States, 11042
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, United States, 27103
Oregon Health and Science University-Dept. of Otolaryngology Head and Neck Surgery
Portland, Oregon, United States, 97239
Bethlehem ENT Specialty Physicians Associates
Bethlehem, Pennsylvania, United States, 18017
University of Pennsylvania, Dept of Otolaryngology-Head & Neck Surgery
Philadelphia, Pennsylvania, United States, 19104
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Intermountain Ear, Nose & Throat Center
Salt Lake City, Utah, United States, 84102
Eastern Virginia Medical School Department of Otolaryngology
Norfolk, Virginia, United States, 23507
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53266
Trial results for NCT01732536
Participant Flow: Overall Study
52 / 53
Completed / Started
46 / 47
Completed / Started
Serious Adverse Events
0 / 106
Affected / At Risk
1 / 94
Affected / At Risk
Other Adverse Events
38 / 53
Affected / At Risk
36 / 47
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT01732536. The sponsor of the trial is Intersect ENT and it is looking for 100 volunteers for the current phase.
Official trial 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
1What's a trial
4Get in touch
What's a trial
Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.
Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.
Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.
Get in touch
You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.
Thank you for applying!
We'll contact you soon with more information.
Consult your doctor?
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.