S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps



Status:Completed
Conditions:Sinusitis
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:18 - Any
Updated:8/17/2018
Start Date:December 2014
End Date:October 2016

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A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Sinus Obstruction

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.

The RESOLVE II Study is a randomized, sham-controlled, double-blind, parallel arm multicenter
trial conducted in up to 45 clinical centers (academic and private) across the United States
in 300 adults with chronic sinusitis, who are indicated for revision surgery because of
recurring nasal obstruction/congestion symptoms and bilateral ethmoid polyposis.

Key inclusion criteria:

- 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

Exclusion criteria:

- 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

- 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
We found this trial at
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Peter Manes, MD
Phone: 203-584-8404
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Do-Yeon Cho, MD
Phone: 205-934-9714
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Scott Stringer, MD
Phone: 601-984-4550
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Roy Casiano, MD
Phone: 305-243-7102
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Norfolk, Virginia 23507
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Jeremiah Alt, MD
Phone: 801-587-8368
University of Utah Research is a major component in the life of the U benefiting...
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Albany, New York 12206
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Albuquerque, New Mexico 87109
Principal Investigator: Roland Gerencer, MD
Phone: 505-944-9599
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Atlanta, Georgia 30342
Principal Investigator: J. Pablo Stolovitzky, MD
Phone: 404-297-4230
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Baltimore, Maryland 21218
(410) 516-8000
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Berkeley Heights, New Jersey 07922
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Bethlehem, Pennsylvania 18017
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Rodney Schlosser, MD
Phone: 843-792-7165
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Chicago, Illinois 60611
Principal Investigator: Bruce Tan, MD
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Colorado Springs, Colorado 80909
Principal Investigator: J. Lewis Romett, MD
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Concord, North Carolina 29025
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Covington, Louisiana 70433
Principal Investigator: Kevin McLaughlin, MD
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Houston, Texas 77030
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Irvine, California 92618
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: David Beahm, MD
Phone: 913-588-3759
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Louisville, Kentucky 40207
Principal Investigator: Andrew Gould, MD
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Miami, Florida 33176
Principal Investigator: William Brown, MD
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Milwaukee, Wisconsin 53227
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Naperville, Illinois 60563
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Rakesh Chandra, MD
Phone: 615-322-0333
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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New York, New York 10029
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New York, New York 10016
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
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