Rates of Middle Meatus Synechiae Formation Post ESS

Not Applicable

Terminated

• Conditions: Sinusitis
• Interventions: Device: steroid eluting spacer

• Registration Number: NCT03036735
• Lead Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-04-05
• Study First Submitted: 2015-05-04
• Primary Completion: 2016-04-05
• Study Completion: 2016-12
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-30
• Results First Submitted: 2018-04-19
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-18
• Last Update Submitted: 2018-10-18
• Results First Posted: 2018-10-19
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Age between 18 and 75 years
2. Diagnosis of chronic rhinosinusitis (CRS), per current guidelines
3. Patients who need to undergo primary bilateral complete endoscopic sinus surgery
4. 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
5. 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

1. Subject is pregnant or breast feeding
2. Patients with sino-nasal tumors
3. Patients solely undergoing nasal septal reconstruction
4. Patients with previous history of endoscopic sinus surgery
5. Cystic fibrosis or syndromic patients
6. Patients with autoimmune diseases
7. Patients who have taken oral steroids less than 30 days prior to surgery
8. Patients with a history or diagnosis of glaucoma or ocular hypertension
9. Any other circumstance or condition that in the Investigator's opinion causes the subject to be an inappropriate candidate for participating in this study

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Steroid Eluting Spacer	steroid eluting spacer	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.

Primary Outcome Measures

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