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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)

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

December 2, 2010
May 26, 2015
December 2009
October 2010   (final data collection date for primary outcome measure)
  • 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
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Complete list of historical versions of study NCT01253577 on ClinicalTrials.gov Archive Site
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.
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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
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
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 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Sinusitis
  • Device: Sinus Stent with drug coating
    Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
  • Device: Non Coated Sinus Stent
    Sinus stent (visually identical) without drug coating
  • Active Comparator: Drug Coated
    Sinus stent coated with steroid
    Intervention: Device: Sinus Stent with drug coating
  • Placebo Comparator: Non coated
    Sinus stent without drug coating
    Intervention: Device: Non Coated Sinus Stent
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01253577
P500-1009
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Intersect ENT
Intersect ENT
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Principal Investigator: Bradley Marple, MD University of Texas
Principal Investigator: Neil Bhattacharyya, MD Brighan & Women's Hospital
Intersect ENT
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP