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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Coated | Active Comparator | Sinus stent coated with steroid |
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| Non coated | Placebo Comparator | Sinus stent without drug coating |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinus Stent with drug coating | Device | Sinus stent coated with 370 ug of the corticosteroid mometasone furoate |
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| 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 |
| 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 |
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Inclusion Criteria:
CT Imaging Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Marple, MD | University of Texas | Principal Investigator |
| Neil Bhattacharyya, MD | Brighan & Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central California ENT | Fresno | California | 93720 | United States | ||
| Colorado ENT & Allergy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22550039 | Result | 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. |
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Sinus randomization was performed at the end of successful endoscopic sinus surgery.
Patients were recruited in the United States between December 2009 and July 2010 from eleven otolaryngology-head and neck surgery centers by 31 surgeons representing both academic and private practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sinus Stent | Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design. |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| Non Coated Sinus Stent | Device | Sinus stent (visually identical) without drug coating |
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| Colorado Springs |
| Colorado |
| 80909 |
| United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Northshore University Health System | Evanston | Illinois | 60201 | United States |
| Advanced ENT & Allergy | Louisville | Kentucky | 40207 | United States |
| Charlotte Eye, ENT Associates | Charlotte | North Carolina | 28210 | United States |
| Austin ENT Clinics | Austin | Texas | United States |
| University of Texas SW Medical School | Dallas | Texas | United States |
| University of Texas Medical School | Houston | Texas | 77098 | United States |
| Intermountain ENT | Salt Lake City | Utah | 84102 | United States |
| Eastern Virgina Medical School | Norfolk | Virginia | 23507 | United States |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sinus Stent | Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | All 105 subjects were present for the primary endpoint exam. However n=96 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel. | Posted | Mean | 95% Confidence Interval | percentage of sinuses | 30-days |
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| 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 | Two patients did not have their ocular exam performed at day 90 (LTFU) but had ocular exams at earlier time points. | Posted | Mean | 95% Confidence Interval | percentage of patients | 90 days |
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| 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. | All 105 subjects were present for this endpoint exam. However n=85 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel. | Posted | Mean | 95% Confidence Interval | percentage of sinuses | 30 days |
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3 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Patients served as their own controls in the study, with a drug-coated stent placed on one sinus side and a non-drug-coated control placed on contralateral side. Therefore adverse events are listed for the entire 105-patient cohort rather than by treatment group. | 0 | 105 | 45 | 105 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Stambaugh, Vice President Clinical Affairs | Intersect ENT | 650-641-2103 | jstambaugh@intersectent.com |
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