A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis (ADVANCE II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intersect ENT
ClinicalTrials.gov Identifier:
NCT01253577
First received: December 2, 2010
Last updated: May 26, 2015
Last verified: May 2015
  Purpose

The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).


Condition Intervention Phase
Chronic Sinusitis
Device: Sinus Stent with drug coating
Device: Non Coated Sinus Stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

Resource links provided by NLM:


Further study details as provided by Intersect ENT:

Primary Outcome Measures:
  • Percentage of Sinuses Requiring Post-operative Intervention [ Time Frame: 30-days ] [ Designated as safety issue: No ]
    Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.

  • Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    clinically significant IOP elevation is a change from baseline of >10 mm Hg on sinus side with drug-coated implant but not on side with control implant


Secondary Outcome Measures:
  • Percentage of Sinuses That Developed Frank Polyposis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.


Enrollment: 105
Study Start Date: December 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Drug Coated
Sinus stent coated with steroid
Device: Sinus Stent with drug coating
Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
Placebo Comparator: Non coated
Sinus stent without drug coating
Device: Non Coated Sinus Stent
Sinus stent (visually identical) without drug coating

Detailed Description:

The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS). The Propel implant is designed to provide a mechanical spacing function within the sinus anatomy to separate mucosal tissues, provide stabilization of the middle turbinate, and thereby prevent tissue adhesions from forming. The implant is coated with a small amount of mometasone furoate (a corticosteroid) in order to help minimize post surgical inflammation within the supported tissues.

The study utilizes an intra-patient control design to assess the safety and efficacy of the drug-coated implant compared to the non-drug coated implant that is identical in appearance.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has bilateral chronic sinusitis confirmed by CT scan and defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive weeks' duration.
  • Patient is indicated for and has consented to FESS.
  • FESS successfully completed without significant complication that in the opinion of the physician would confound study results and the patient's anatomy remains amenable to Sinus Stent placement.

CT Imaging Inclusion Criteria:

  • CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.
  • Patient has minimum total CT score (Lund-Mackay method) of 6. • Patient has bilateral ethmoid sinus disease confirmed by CT.

Exclusion Criteria:

  • insulin dependent diabetics
  • oral steroid dependent condition
  • glaucoma, ocular hypertension, posterior subcapsular cataracts
  • middle turbinate resection
  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: NCT01253577

Locations
United States, California
Central California ENT
Fresno, California, United States, 93720
United States, Colorado
Colorado ENT & Allergy
Colorado Springs, Colorado, United States, 80909
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Northshore University Health System
Evanston, Illinois, United States, 60201
United States, Kentucky
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40207
United States, North Carolina
Charlotte Eye, ENT Associates
Charlotte, North Carolina, United States, 28210
United States, Texas
Austin ENT Clinics
Austin, Texas, United States
University of Texas SW Medical School
Dallas, Texas, United States
University of Texas Medical School
Houston, Texas, United States, 77098
United States, Utah
Intermountain ENT
Salt Lake City, Utah, United States, 84102
United States, Virginia
Eastern Virgina Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Intersect ENT
Investigators
Principal Investigator: Bradley Marple, MD University of Texas
Principal Investigator: Neil Bhattacharyya, MD Brighan & Women's Hospital
  More Information

Publications:
Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT01253577     History of Changes
Other Study ID Numbers: P500-1009
Study First Received: December 2, 2010
Results First Received: December 11, 2012
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 30, 2015