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

Primary Purpose

Chronic Sinusitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sinus Stent with drug coating
Non Coated Sinus Stent
Sponsored by
Intersect ENT
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central California ENT
  • Colorado ENT & Allergy
  • Northwestern University
  • Northshore University Health System
  • Advanced ENT & Allergy
  • Charlotte Eye, ENT Associates
  • Austin ENT Clinics
  • University of Texas SW Medical School
  • University of Texas Medical School
  • Intermountain ENT
  • Eastern Virgina Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Drug Coated

Non coated

Arm Description

Sinus stent coated with steroid

Sinus stent without drug coating

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.

Full Information

First Posted
December 2, 2010
Last Updated
May 26, 2015
Sponsor
Intersect ENT
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1. Study Identification

Unique Protocol Identification Number
NCT01253577
Brief Title
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
Acronym
ADVANCE II
Official Title
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intersect ENT

4. Oversight

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Coated
Arm Type
Active Comparator
Arm Description
Sinus stent coated with steroid
Arm Title
Non coated
Arm Type
Placebo Comparator
Arm Description
Sinus stent without drug coating
Intervention Type
Device
Intervention Name(s)
Sinus Stent with drug coating
Intervention Description
Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
Intervention Type
Device
Intervention Name(s)
Non Coated Sinus Stent
Intervention Description
Sinus stent (visually identical) without drug coating
Primary Outcome Measure Information:
Title
Percentage of Sinuses Requiring Post-operative Intervention
Description
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.
Time Frame
30-days
Title
Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure
Description
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
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Percentage of Sinuses That Developed Frank Polyposis
Description
Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Marple, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil Bhattacharyya, MD
Organizational Affiliation
Brighan & Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central California ENT
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Colorado ENT & Allergy
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northshore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Advanced ENT & Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Charlotte Eye, ENT Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Austin ENT Clinics
City
Austin
State/Province
Texas
Country
United States
Facility Name
University of Texas SW Medical School
City
Dallas
State/Province
Texas
Country
United States
Facility Name
University of Texas Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Intermountain ENT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Eastern Virgina Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22550039
Citation
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.
Results Reference
result

Learn more about this trial

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

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