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Safety and Efficacy of a Steroid-Releasing Sinus Implant for Recurrent Sinus Obstruction (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: March 19, 2017
Last verified: March 2017

November 14, 2012
March 19, 2017
January 2013
November 2013   (Final data collection date for primary outcome measure)
  • nasal obstruction/congestion [ Time Frame: 3 months ]
  • nasal polyposis [ Time Frame: 3 months ]
Same as current
Complete list of historical versions of study NCT01732536 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy of a Steroid-Releasing Sinus Implant for Recurrent Sinus Obstruction
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 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Outcomes Assessor
Primary Purpose: Treatment
Chronic Sinusitis
  • 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
  • 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
  • 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)
    Intervention: Drug: S8 Sinus Implant
  • Sham Comparator: Control
    Bilateral in-office sham procedure in the ethmoid sinuses and continued Nasonex (mometasone furoate nasal spray, 200 mcg)
    Intervention: Procedure: Sham procedure
Han JK, Forwith KD, Smith TL, Kern RC, Brown WJ, Miller SK, Ow RA, Poetker DM, Karanfilov B, Matheny KE, Stambaugh J, Gawlicka AK. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014 Nov;4(11):861-70. doi: 10.1002/alr.21426. Epub 2014 Sep 29.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01732536
P500-1012
Yes
Not Provided
No
No plan
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
March 2017

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