Clinical trial NCT01253577: A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Sinusitis
Lead sponsor: Intersect ENT
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Sinuses Requiring Post-operative Intervention
timeFrame: 30-days
measure: Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure
timeFrame: 90 days
Secondary outcomes:
measure: Percentage of Sinuses That Developed Frank Polyposis
timeFrame: 30 days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central California ENT
state: California
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: Northshore University Health System
state: Illinois
city: Louisville
country: United States
facility: Advanced ENT & Allergy
state: Kentucky
city: Charlotte
country: United States
facility: Charlotte Eye, ENT Associates
state: North Carolina
city: Austin
country: United States
facility: Austin ENT Clinics
state: Texas
city: Dallas
country: United States
facility: University of Texas SW Medical School
state: Texas
city: Houston
country: United States
facility: University of Texas Medical School
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain ENT
state: Utah
city: Norfolk
country: United States
facility: Eastern Virgina Medical School
state: Virginia
Study officials:
affiliation: University of Texas
name: Bradley Marple, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brighan & Women's Hospital
name: Neil Bhattacharyya, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.