Trial record 7 of 16 for:    feinberg school of medicine OR northwestern university medical school | sinus

Safety and Efficacy of Bioabsorbable Drug-Eluting Sinus Implant for Chronic Sinusitis (RESOLVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intersect ENT
ClinicalTrials.gov Identifier:
NCT01732536
First received: November 14, 2012
Last updated: June 17, 2014
Last verified: June 2014
  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
Drug: continued nasal steroid spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • nasal polyposis [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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: Drug Eluting Sinus Implant
S8 steroid eluting sinus implant and continued nasal steroid spray
Drug: S8 sinus implant
Sham Comparator: Control
continued nasal steroid spray
Drug: continued nasal steroid spray

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT01732536     History of Changes
Other Study ID Numbers: P500-1012
Study First Received: November 14, 2012
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014