SinusitisDELIVERNCT00791934
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide
A study testing Stratus Microflow Ethmoid Spacer in people with Sinusitis, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
Study Design: A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- Stratus Microflow Ethmoid Spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Nov 2011
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects age 17 years or older
- Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery)
- Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)
Who cannot join
- Age < 17 years old
- History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP >21 mmHg)
- Adequate anatomical distances for treatment
- Patient received oral steroid treatment within two weeks prior to day of surgery
- Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement
- Sinonasal tumors or obstructive lesions
Show all 14Show fewer
- History of facial trauma that distorts sinus anatomy and precludes access to the ethmoid sinus
- Contracted/underdeveloped ethmoid sinus
- Dehiscent lamina orbitalis
- Previous ethmoid surgery
- Ethmoid mucocele
- Extensive Nasal Polyps
- Asthmatic patients with aspirin sensitivity
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)
Study Design:
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.
- Conditions
- Sinusitis
- Being tested
- Stratus Microflow Ethmoid Spacer
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stratus Microflow Ethmoid SpacerDevice
Also called Ethmoid Spacer
The Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone acetonide will be administered into the Spacer for this investigational study. The Spacer will be left in the ethmoid sinus for a period of 28 days. At the end of the implant period, the device is removed with standard instrumentation, during a follow-up office visit.
| Study group | Role | What they receive |
|---|---|---|
| Stratus Microflow Ethmoid Spacer | Experimental | Temporary implantation of Ethmoid spacer with Triamcinolone Acetonide for 28 days. Receives: Device: Stratus Microflow Ethmoid Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.
The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.
Measured: 10 weeks post-procedure
Secondary outcomes (4)
Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)
The Snellen eye chart will be used to evaluate participant's best-corrected visual acuity (BCVA, or best distance vision with eyeglasses or contact lenses) at baseline and at 10 week post-procedure. The number of participants with a decrease in vision greater than 2 lines per the Snellen eye chart are reported for this study endpoint.
Measured: 10 weeks post surgery
Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg
Change in Intra-Ocular Pressure (IOP) of ≥ 10mmHg or documented IOP of > 21 mmHg were considered clinically significant (baseline compared to 10 weeks post-procedure).
Measured: 10 weeks post-procedure
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.
Measured: 1 year
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 10 weeks, and 1 year post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2011
- Study completionNov 2011
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
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Peter Catalano, MD, Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791934
- Sponsor's protocol ID
- CPR005003
- Acronym
- DELIVER
- Status last verified
- Jul 2024
- First submitted
- 13 Nov 2008
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide (Kenalog-40)
- ClinicalTrials.gov ID
- NCT00791934
- Acronym / sponsor ID
- DELIVER / CPR005003
- Conditions
- Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- Aug 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Posted 14 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Design:
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of treating the ethmoid sinuses with the Ethmoid Sinus Spacer and Access System used for the local delivery of Triamcinolone Acetonide, over a period of 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stratus Microflow Ethmoid Spacer | Experimental | Device: Stratus Microflow Ethmoid SpacerTemporary implantation of Ethmoid spacer with Triamcinolone Acetonide for 28 days. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects age 17 years or older
- Radiographic evidence of ethmoid disease (baseline CT scan obtained within 30 days of scheduled surgery)
- Diagnosis of chronic sinusitis and failed medical management (minimum of 3 weeks of antibiotics)
Key exclusion criteria (14 listed)
- Age < 17 years old
- History of glaucoma or diagnosis of glaucoma (baseline visual exam indicating IOP >21 mmHg)
- Adequate anatomical distances for treatment
- Patient received oral steroid treatment within two weeks prior to day of surgery
- Radiographic evidence of extensive sinonasal osteoneogenesis which could prevent device placement
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 |
|---|---|---|
| Stratus Microflow Ethmoid SpacerAlso: Ethmoid SpacerThe Spacer is inserted surgically into the ethmoid complex through the use of a sinus access system. Triamcinolone acetonide will be administered into the Spacer for this investigational study. The Spacer will be left in the ethmoid sinus for a period of 28 days. At the end of the implant period, the device is removed with standard instrumentation, during a follow-up office visit. | Device | Stratus Microflow Ethmoid Spacer |
Primary outcome
Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.
Time frame: 10 weeks post-procedure
The Lund-MacKay (LMK) CT (computed tomography) scoring system is used to evaluate radiographic opacification of the paranasal sinuses, an indicator of sinus disease. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. For this study endpoint, only the ethmoid sinus scores will be evaluated and totaled (left and right anterior and posterior ethmoid sinuses) where zero is the minimum score, and 8 is the maximum score. A higher score represents greater sinus disease burden. The LMK score will be evaluated at 10 weeks post-procedure compared to baseline.
4 secondary outcomes
Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)
Time frame: 10 weeks post surgery
Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg
Time frame: 10 weeks post-procedure
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
Time frame: 1 year
Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- 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.
Peter Catalano, MD principal investigator
Lahey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stratus Microflow Ethmoid Spacer in people with Sinusitis, run by Integra LifeSciences Corporation 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 3 inclusion and 14 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 6 Aug 2024. 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 14 Jul 2014). 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?
Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline. (time frame: 10 weeks post-procedure). 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 6 Aug 2024.