Rates of Middle Meatus Synechiae Formation Post ESS

NCT ID: NCT03036735

Last Updated: 2018-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-05
• Study Completion Date: 2016-12-31

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.

Conditions

Sinusitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

steroid eluting spacer

Intervention Type: DEVICE

The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.

Interventions

steroid eluting spacer

The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SinuSys Corporation

INDUSTRY

Sponsor Role: collaborator

Steward St. Elizabeth's Medical Center of Boston, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Peter Catalano

Director otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

00723

Identifier Type: -

Identifier Source: org_study_id