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

Chronic Sinusitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253577
• Other study ID #: P500-1009
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2010
• Last updated: May 26, 2015
• Start date: December 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2015
• Source: Intersect ENT
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• Sinus Stent with drug coating
Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
• Non Coated Sinus Stent
Sinus stent (visually identical) without drug coating

Locations

Country	Name	City	State
United States	Austin ENT Clinics	Austin	Texas
United States	Charlotte Eye, ENT Associates	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Colorado ENT & Allergy	Colorado Springs	Colorado
United States	University of Texas SW Medical School	Dallas	Texas
United States	Northshore University Health System	Evanston	Illinois
United States	Central California ENT	Fresno	California
United States	University of Texas Medical School	Houston	Texas
United States	Advanced ENT & Allergy	Louisville	Kentucky
United States	Eastern Virgina Medical School	Norfolk	Virginia
United States	Intermountain ENT	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intersect ENT

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	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	No