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Clinical Evaluation of Safety and Efficacy of S8 Sinus Implant in Chronic Sinusitis Patients (RESOLVEII)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02291549
First Posted: November 14, 2014
Last Update Posted: August 18, 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 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.

Condition Intervention Phase
Chronic Sinusitis Nasal Polyposis Drug: S8 Sinus Implant Drug: Nasonex steroid nasal spray Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: RESOLVE II: A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Sinus Obstruction

Resource links provided by NLM:


Further study details as provided by Intersect ENT:

Primary Outcome Measures:
  • Change in Nasal Obstruction/Congestion Score from baseline to Day 30 [ Time Frame: 30 Day ]
    Determined by patient using a daily diary

  • Change in bilateral polyp grade from baseline to Day 90 [ Time Frame: 90 Day ]
    Determined from video-endoscopies reviewed by a panel of independent, blinded sinus surgeons.


Enrollment: 300
Study Start Date: December 2014
Study Completion Date: October 2016
Primary Completion Date: October 2016 (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 steroid nasal spray (mometasone furoate, 200 mcg) once daily
Drug: S8 Sinus Implant
Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Other Name: Mometasone furoate sinus implant, 1350 mcg
Drug: Nasonex steroid nasal spray
topical nasal steroid spray 200mcg once daily
Other Name: Mometasone furoate nasal spray, 200 mcg
Sham Comparator: Control
Bilateral in-office sham procedure and continued steroid nasal spray (mometasone furoate, 200 mcg) once daily
Drug: Nasonex steroid nasal spray
topical nasal steroid spray 200mcg once daily
Other Name: Mometasone furoate nasal spray, 200 mcg

Detailed Description:
The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, 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.
  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

Key inclusion criteria:

  • Confirmed diagnosis of chronic sinusitis
  • Previous endoscopic sinus surgery (ESS) including bilateral total ethmoidectomy
  • Nasal obstruction/congestion symptoms despite use of intranasal steroid irrigations or sprays
  • 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

Key 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
  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): NCT02291549


  Show 40 Study Locations
Sponsors and Collaborators
Intersect ENT
Investigators
Principal Investigator: Robert Kern, MD Northwestern Medical Faculty Foundation, Department of Otolaryngology
Principal Investigator: Jose P. Stolovitzky, MD ENT of Georgia/Emory University School of Medicine
  More Information

Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT02291549     History of Changes
Other Study ID Numbers: P500-1113
First Submitted: November 11, 2014
First Posted: November 14, 2014
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Polyps
Pathological Conditions, Anatomical
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents