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Safety and Efficacy of a Steroid-Releasing Sinus Implant for Recurrent Sinus Obstruction (RESOLVE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732536
First Posted: November 26, 2012
Last Update Posted: March 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Intersect ENT
  Purpose
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.

Condition Intervention Phase
Chronic Sinusitis Drug: S8 Sinus Implant Procedure: Sham procedure Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Intersect ENT:

Primary Outcome Measures:
  • nasal obstruction/congestion [ Time Frame: 3 months ]
  • nasal polyposis [ Time Frame: 3 months ]

Enrollment: 100
Study Start Date: January 2013
Study Completion Date: May 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S8 Sinus Implant
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses and continued Nasonex (mometasone furoate nasal spray, 200 mcg)
Drug: S8 Sinus Implant
Bilateral in-office placement of S8 sinus implant with 1350 mcg of mometasone furoate and continued steroid nasal spray (mometasone furoate, 200 mcg) once daily
Other Name: Mometasone furoate sinus implant, 1350 mcg
Sham Comparator: Control
Bilateral in-office sham procedure in the ethmoid sinuses and continued Nasonex (mometasone furoate nasal spray, 200 mcg)
Procedure: Sham procedure
Bilateral in-office sham procedure and continued steroid nasal spray (mometasone furoate, 200 mcg) once daily
Other Name: Bilateral in-office sham procedure in the ethmoid sinuses

Detailed Description:
A significant proportion of patients who undergo sinus surgery for chronic sinusitis later experience recurrent symptoms due to persisting disease and the regrowth of sinus polyps. For many patients this persisting disease proves to be refractory to medical therapy. Treatment options typically include further aggressive medical therapy or repeat sinus surgery. This study is designed to evaluate another treatment option in the form of a steroid-eluting sinus implant that is placed into the sinus and delivers the medication for up to 3 months to reduce sinus inflammation, polyposis and the associated sinus symptoms.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of chronic sinusitis
  • prior sinus surgery with ethmoidectomy
  • recurrent sinus obstruction due to polyps
  • refractory to medical therapy
  • indicated for revision sinus surgery

Exclusion Criteria:

  • significant scarring of the sinus
  • insulin dependent diabetes
  • glaucoma or ocular hypertension
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732536


Locations
United States, California
California Sinus Centers
Atherton, California, United States, 94027
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sacramento Ear, Nose and Throat
Sacramento, California, United States, 95815
United States, Colorado
Colorado Ear, Nose, Throat & Allergy
Colorado Springs, Colorado, United States, 80909
United States, Florida
South Florida ENT Associates
Miami, Florida, United States, 33176
United States, Georgia
ENT of Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern Medical Faculty Foundation, Department of Otolaryngology
Chicago, Illinois, United States, 60611
United States, Kentucky
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40207
United States, New Jersey
Summit Medical Group
Berkley Heights, New Jersey, United States, 07922
United States, New York
Albany ENT & Allergy Services
Albany, New York, United States, 12206
ENT and Allergy Associates
Lake Success, New York, United States, 11042
United States, North Carolina
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Oregon Health and Science University-Dept. of Otolaryngology
Portland, Oregon, United States, 97239
United States, Pennsylvania
Bethlehem ENT Associates
Bethlehem, Pennsylvania, United States, 18017
Perelmen School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Utah
Ear, Nose & Throat Center
Salt Lake City, Utah, United States, 84102
United States, Virginia
Eastern Virginia Medical School Department of Otolaryngology
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53266
Sponsors and Collaborators
Intersect ENT
Investigators
Principal Investigator: Keith Forwith, MD Advanced ENT and Allergy
Principal Investigator: Joseph Han, MD Eastern Virginia Medical School Department of Otolaryngology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT01732536     History of Changes
Other Study ID Numbers: P500-1012
First Submitted: November 14, 2012
First Posted: November 26, 2012
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents