Rates of Middle Meatus Synechiae Formation Post ESS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03036735
Recruitment Status : Terminated (Sponsor withdrew funds)
First Posted : January 30, 2017
Last Update Posted : February 2, 2017
SinuSys Corporation
Information provided by (Responsible Party):
Peter Catalano, 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.

Condition or disease Intervention/treatment Phase
Sinusitis Device: steroid eluting spacer Not Applicable

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  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention 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.
Primary Purpose: Treatment
Official Title: Rates of Middle Meatus (MM) Synechiae Formation Post Endoscopic Sinus Surgery (ESS)
Study Start Date : May 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

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.

Primary Outcome Measures :
  1. Incidence of middle meatal synechiae [ Time Frame: 90 days ]
    Safety and effectiveness of 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 :
  1. sinonasal mucosal inflammation [ Time Frame: 90 days ]
    35 and 90-day sinonasal mucosal inflammation will be assessed by rigid endoscopy and graded on both the Philpott-Javer and Modified Lund-Kennedy sinus mucosal endoscopic staging systems

  2. intraocular pressure (IOP) [ Time Frame: 90 days ]
    35 and 90-day intraocular pressure (IOP) will be assessed using applanation tonometry and compared to baseline IOP obtained preoperatively

  3. postoperative interventions [ Time Frame: 35 days ]
    35-day frequency of postoperative interventions, including lyses of adhesions and debridement.

  4. SNOT-22 Questionnaire [ Time Frame: 90 days ]
    90-day validated Sinonasal Outcomes Test-22 (SNOT- 22) scores

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Peter Catalano, Director otolaryngology, Steward St. Elizabeth's Medical Center of Boston, Inc. Identifier: NCT03036735     History of Changes
Other Study ID Numbers: 00723
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases