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Rates of Middle Meatus Synechiae Formation Post ESS

Primary Purpose

Sinusitis

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

steroid eluting spacer

About this trial

This is an interventional treatment trial for Sinusitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Steroid Eluting Spacer

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03036735

First Posted

May 4, 2015

Last Updated

October 18, 2018

Sponsor

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

Collaborators

SinuSys Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03036735

Brief Title

Rates of Middle Meatus Synechiae Formation Post ESS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Terminated

Why Stopped

Sponsor withdrew funds

Study Start Date

April 5, 2015 (Actual)

Primary Completion Date

April 5, 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

SinuSys Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sinusitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Masking Description

At the end of surgery, the Surgery Fellow will insert either the Drug Eluting Spacer or the Silastic spacer into each side of the subject's nose. The subject will receive one of each spacer. The fellow will record which spacer was placed on which side using a special coding system to keep this information private. This maintains the blinding for the primary surgeon/outcome assessor and subject.

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Steroid Eluting Spacer

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

steroid eluting spacer

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery )," as Accurate and Appropriate).

Description

Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.

Time Frame

35 to 90days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Rates of Middle Meatus Synechiae Formation Post ESS

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