SinusitisNCT03036735
Rates of Middle Meatus Synechiae Formation Post ESS
A study testing steroid eluting spacer in people with Sinusitis, run by Steward St. Elizabeth's Medical Center of Boston, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- steroid eluting spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 5 Apr 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- steroid eluting spacer
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroid eluting spacerDevice
The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.
| Study group | Role | What they receive |
|---|---|---|
| Steroid Eluting Spacer | Experimental | 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. Receives: Device: steroid eluting spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 35 to 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start5 Apr 2015
- Primary completion5 Apr 2016
- Study completionDec 2016
Why it stopped: Sponsor withdrew funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- SinuSys Corporation
- Responsible party
- Principal investigator, Peter Catalano, Steward St. Elizabeth's Medical Center of Boston, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036735
- Sponsor's protocol ID
- 00723
- Status last verified
- Oct 2018
- First submitted
- 4 May 2015
- Last updated
- 19 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rates of Middle Meatus (MM) Synechiae Formation Post Endoscopic Sinus Surgery (ESS)
- ClinicalTrials.gov ID
- NCT03036735
- Acronym / sponsor ID
- 00723
- Conditions
- Sinusitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew funds
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.University, hospital or other
- Collaborators
- SinuSys Corporation
- Study start
- 5 Apr 2015 (actual)
- Primary completion
- 5 Apr 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 19 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Steroid Eluting Spacer | Experimental | Device: steroid eluting spacerSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steroid eluting spacerThe Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer. | Device | Steroid Eluting Spacer |
Primary outcome
Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery )," as Accurate and Appropriate).
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing steroid eluting spacer in people with Sinusitis, run by Steward St. Elizabeth's Medical Center of Boston, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery )," as Accurate and Appropriate). (time frame: 35 to 90days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.