Trial record 5 of 18 for:    feinberg school of medicine OR northwestern university medical school | sinus

RESOLVE II Clinical Evaluation of Safety and Efficacy of S8 Sinus Implant in Chronic Sinusitis Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intersect ENT
ClinicalTrials.gov Identifier:
NCT02291549
First received: November 11, 2014
Last updated: August 19, 2016
Last verified: August 2016
  Purpose
The RESOLVE II Study will assess the safety and efficacy of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who present with recurrent sinus obstruction. This is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study that will enroll 300 patients.

Condition Intervention Phase
Chronic Sinusitis
Nasal Polyposis
Drug: S8 Sinus Implant
Drug: Control Arm
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    Determined by patient using a daily diary

  • Change in bilateral polyp grade from baseline to Day 90 [ Time Frame: 90 Day ] [ Designated as safety issue: No ]
    Determined from video-endoscopies reviewed by a panel of independent, blinded sinus surgeons.


Enrollment: 300
Study Start Date: December 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
topical nasal steroid spray + S8 Sinus Implant placed in both ethmoid sinuses
Drug: S8 Sinus Implant
S8 Sinus Implant placed in both ethmoid sinuses.
Sham Comparator: Control Arm
Drug: topical nasal steroid spray
Drug: Control Arm
topical nasal steroid spray 200mcg once daily

  Eligibility

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

Adult patients (age ≥ 18 years) diagnosed with chronic sinusitis who underwent prior bilateral total ethmoidectomy but are currently indicated for repeat Endoscopic Sinus Surgery because they present with recurrent symptoms and ethmoid sinus obstruction due to bilateral polyposis (minimum grade 2 on each side), with or without obstructive mucosal edema and/or scarring/adhesions, and in whom placement of the S8 Sinus Implant is both feasible and medically appropriate.

Key Eligibility 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 (e.g. oral, parenteral, injection into polyps) and/or sinus steroid irrigations within the preceding 1 year
  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: 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 
Study First Received: November 11, 2014
Last Updated: August 19, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Sinusitis
Chronic Disease
Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 25, 2016