Chronic SinusitisNCT00912405
Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
A study testing Steroid-Eluting Sinexus Intranasal Splint in people with Chronic Sinusitis, run by Intersect ENT at 1 site in United States.
Trial summary
This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Steroid-Eluting Sinexus Intranasal Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 years of age or older
- Patient has a diagnosis of chronic sinusitis
- Patient has a clinical indication for and has consented to FESS
- Patient CT scan confirms CS diagnosis within 6 months of procedure
- CT sacn confirms presence of disease in ethmoid sinus(es)
- Planned FESS includes unilateral or bilateral total ethmoidectomy
Who cannot join
- Immune deficiency (IGG subclass deficiency or IGA deficiency)
- Oral-steroid dependent COPD, asthma or other condition
- Clinical evidence of acute bacterial sinusitis
- History or diagnosis of glaucoma or ocular hypertension
- Clinical evidence or suspicion of invasive fungal sinusitis
- Evidence of disease or condition expected to compromise survival or ability to complete follow-up
- Known history of allergy or intolerance to corticosteroids
- History of insulin dependent diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Central California Ear, Nose Thraot
Fresno, California
About this study
Official title: A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).
- Conditions
- Chronic Sinusitis
- Being tested
- Steroid-Eluting Sinexus Intranasal Splint
- Keywords
- Patients diagnosed with Chronic Sinusitis undergoing functional endoscopic surgery (FESS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid-Eluting Sinexus Intranasal SplintDevice
Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
| Study group | Role | What they receive |
|---|---|---|
| Sinexus Intranasal Splint | Experimental | Patient receives a drug-coated intranasal splint Receives: Device: Steroid-Eluting Sinexus Intranasal Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)
Measured: 30 days
Device Placement Success Rate
A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.
Measured: At the time of procedure
Secondary outcomes (2)
Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities
Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.
Measured: Baseline and 30 days
Number of Sinuses With Significant Post-operative Adhesion Formation
Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionDec 2009
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 Chronic 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersect ENT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912405
- Sponsor's protocol ID
- P500-0209
- Status last verified
- Mar 2015
- First submitted
- 1 Jun 2009
- Last updated
- 20 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
- ClinicalTrials.gov ID
- NCT00912405
- Acronym / sponsor ID
- P500-0209
- Conditions
- Chronic Sinusitis
- Keywords
- Patients diagnosed with Chronic Sinusitis undergoing functional endoscopic surgery (FESS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Intersect ENTIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 20 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinexus Intranasal Splint | Experimental | Device: Steroid-Eluting Sinexus Intranasal SplintPatient receives a drug-coated intranasal splint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is 18 years of age or older
- Patient has a diagnosis of chronic sinusitis
- Patient has a clinical indication for and has consented to FESS
- Patient CT scan confirms CS diagnosis within 6 months of procedure
- CT sacn confirms presence of disease in ethmoid sinus(es)
Key exclusion criteria (8 listed)
- Immune deficiency (IGG subclass deficiency or IGA deficiency)
- Oral-steroid dependent COPD, asthma or other condition
- Clinical evidence of acute bacterial sinusitis
- History or diagnosis of glaucoma or ocular hypertension
- Clinical evidence or suspicion of invasive fungal sinusitis
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 Sinexus Intranasal SplintIntranasal drug-coated splint placed after functional endoscopic surgery (FESS) | Device | Sinexus Intranasal Splint |
Primary outcome
Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)
Time frame: 30 days
Device Placement Success Rate
Time frame: At the time of procedure
A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.
2 secondary outcomes
Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities
Time frame: Baseline and 30 days
Number of Sinuses With Significant Post-operative Adhesion Formation
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steroid-Eluting Sinexus Intranasal Splint in people with Chronic Sinusitis, run by Intersect ENT at 1 site in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 20 Apr 2015). 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?
Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) (time frame: 30 days). The study lists 2 primary outcomes in all. 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 20 Apr 2015.