Sinusitis
Conditions
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.
Interventions
DEVICEsteroid eluting spacer
The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.
Sponsors
SinuSys Corporation
Steward St. Elizabeth's Medical Center of Boston, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Pre-assignment details
Study was terminated prematurely
Participants by arm
| Arm | Count |
|---|---|
| Drug Eluding Spacer nasal drug eluding spacer | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Drug Eluding Spacer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 35 to 90days
Population: Study was terminated , funds withdrawn. No data was collected or analyzed.