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

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).

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis
• Intervention / Treatment: Device: Sinus Stent with drug coating; Device: Non Coated Sinus Stent

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Central California ENT
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Colorado ENT & Allergy
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Evanston, Illinois, United States, 60201
      • NorthShore University Health System
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Advanced ENT & Allergy
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye, ENT Associates
  • Texas
    • Austin, Texas, United States
      • Austin ENT Clinics
    • Dallas, Texas, United States
      • University of Texas SW Medical School
    • Houston, Texas, United States, 77098
      • University of Texas Medical School
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Intermountain ENT
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virgina Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Sinuses Requiring Post-operative Intervention	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.	30-days
Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure	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	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Sinuses That Developed Frank Polyposis	Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.	30 days

Collaborators and Investigators

• Sponsor: Intersect ENT
• Investigators: Principal Investigator: Bradley Marple, MD, University of Texas; Principal Investigator: Neil Bhattacharyya, MD, Brighan & Women's Hospital

Publications and helpful links

General Publications

• Han JK, Marple BF, Smith TL, Murr AH, Lanier BJ, Stambaugh JW, Mugglin AS. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol. 2012 Jul-Aug;2(4):271-9. doi: 10.1002/alr.21044. Epub 2012 May 1.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: December 2, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Estimate): June 22, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Chronic Disease
• Other Study ID Numbers: P500-1009