Rates of Middle Meatus Synechiae Formation Post ESS

Study Overview
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Brief Summary
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The study is designed to evaluate if addition of the steroid to the spacer / stent will improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.

Detailed Description
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The study is designed to evaluate basic device usability and confirm safety and effectiveness of the Restora Steroid Eluting spacer compared to a Silastic spacer. At the completion of their procedure, patients undergoing ESS will receive one steroid eluting spacer placed into the surgical site on one side, and one spacer without drug placed on the other side. Patients will return for standard post-op visits. Between post-op day 6 and 8, both spacers will be removed. Patients will again be seen on post-op day 35 and 90 to evaluate the surgical sites with respect to healing, scarring, infection, degree of inflammation, polyp formation, and the need for secondary intervention. Data from the two sides will be compared to determine if there is a benefit derived from the spacer with steroid vs the one without.

Official Title
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Rates of Middle Meatus (MM) Synechiae Formation Post Endoscopic Sinus Surgery (ESS)

Conditions
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Sinusitis

Intervention / Treatment
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* Device: steroid eluting spacer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 years Diagnosis of chronic rhinosinusitis (CRS), per current guidelines Patients who need to undergo primary bilateral complete endoscopic sinus surgery Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments Subject must understand the research nature of this study and sign an informed consent prior to the performance of any study-specific procedure or assessment Exclusion Criteria Subject is pregnant or breast feeding Patients with sino-nasal tumors Patients solely undergoing nasal septal reconstruction Patients with previous history of endoscopic sinus surgery Cystic fibrosis or syndromic patients Patients with autoimmune diseases Patients who have taken oral steroids less than 30 days prior to surgery Patients with a history or diagnosis of glaucoma or ocular hypertension Any other circumstance or condition that in the Investigator's opinion causes the subject to be an inappropriate candidate for participating in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects undergoing endoscopic sinus surgery (ESS) will receive one steroid eluting spacer placed into the surgical site on one side, and one spacer without steroid placed on the other side.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steroid Eluting Spacer<br>Subjects will receive one steroid eluting spacer (Restora Mometasone Furate Eluting Spacer) placed into the surgical site on one side, and one spacer without drug (Silastic spacer) placed on the other side. The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer. | Device: steroid eluting spacer<br>* The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery ), as Accurate and Appropriate). | Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae. | 35 to 90days |