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

November 14, 2012
June 17, 2014
January 2013
November 2013   (final data collection date for primary outcome measure)
  • nasal obstruction/congestion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • nasal polyposis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01732536 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Safety and Efficacy of Bioabsorbable Drug-Eluting Sinus Implant for Chronic Sinusitis
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Sinusitis
  • Drug: S8 sinus implant
  • Drug: continued nasal steroid spray
  • Experimental: Drug Eluting Sinus Implant
    S8 steroid eluting sinus implant and continued nasal steroid spray
    Intervention: Drug: S8 sinus implant
  • Sham Comparator: Control
    continued nasal steroid spray
    Intervention: Drug: continued nasal steroid spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2014
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01732536
P500-1012
Yes
Intersect ENT
Intersect ENT
Not Provided
Principal Investigator: Keith Forwith, MD Advanced ENT and Allergy
Principal Investigator: Joseph Han, MD Eastern Virginia Medical School Department of Otolaryngology
Intersect ENT
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP