Rates of Middle Meatus Synechiae Formation Post ESS

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

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.

Study Overview

• Status: Terminated
• Conditions: Sinusitis
• Intervention / Treatment: Device: steroid eluting spacer

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: steroid eluting spacer; The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
• Collaborators: SinuSys Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2015
• Primary Completion (Actual): April 5, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 4, 2015
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: 00723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES