Sinusitis, Chronic RhinosinusitisSPACERNCT01054703
Clinical Evaluation of the Ethmoid Sinus Spacer
A study testing Ethmoid Sinus Spacer in people with Sinusitis, Chronic Rhinosinusitis, run by Integra LifeSciences Corporation at 1 site in United States.
Trial summary
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sinusitis, Chronic Rhinosinusitis
- What is being tested?
- Ethmoid Sinus Spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2007to 1 Nov 2007
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 21 years old
- Both male and female
- Ethmoid disease on CT scan
- At least one non-ethmoid sinus requiring treatment
- Failed medical management and symptomatic
Who cannot join
- Previous ethmoid surgery
- Not sufficient room for placement of Spacer
- Patient requires septoplasty
- Has received steroid treatment with in 2 weeks
- Extensive sinonasal osteoneogenesis preventing device placement
- Sinonasal tumors or obstructive lesions
Show all 9Show fewer
- History of facial trauma that distorts sinus anatomy
- Asthmatic patients with aspirin sensitivity
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Nasal and Sinus Institute
Savannah, Georgia, 31404
About this study
Official title: Clinical Evaluation of the Safety and Feasibility of the Ethmoid Sinus Spacer and Access System With Drug (SPACER)
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
- Conditions
- Sinusitis, Chronic Rhinosinusitis
- Being tested
- Ethmoid Sinus Spacer
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethmoid Sinus SpacerDevice
Also called Acclarent Ethmoid Sinus Spacer and Access System
Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
| Study group | Role | What they receive |
|---|---|---|
| Ethmoid Sinus Spacer placement | Experimental | Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40 Receives: Device: Ethmoid Sinus Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant
Measured: Procedural and 6 weeks post-implant
Secondary outcomes (1)
Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures
Measured: 1 wk, 2wk, 4wk, 6wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study start1 Apr 2007
- Primary completion1 Nov 2007
- Study completion1 Nov 2007
Why it stopped: Interim assessment performed after 14 patients provided evidence that further enrollment was not required to achieve intended endpoints of the study.
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 Sinusitis, Chronic RhinosinusitisStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Responsible party
- Sponsor
- Investigators
- Fred Kuhn, MD, Principal investigator, Georgia Nasal and Sinus Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054703
- Sponsor's protocol ID
- CPR02082
- Acronym
- SPACER
- Status last verified
- Jul 2024
- First submitted
- 20 Jan 2010
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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 Evaluation of the Safety and Feasibility of the Ethmoid Sinus Spacer and Access System With Drug (SPACER)
- ClinicalTrials.gov ID
- NCT01054703
- Acronym / sponsor ID
- SPACER / CPR02082
- Conditions
- Sinusitis, Chronic Rhinosinusitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim assessment performed after 14 patients provided evidence that further enrollment was not required to achieve intended endpoints of the study.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Acclarent
- Study start
- 1 Apr 2007 (actual)
- Primary completion
- 1 Nov 2007 (actual)
- Study completion
- 1 Nov 2007 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Posted 24 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ethmoid Sinus Spacer placement | Experimental | Device: Ethmoid Sinus SpacerEthmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 21 years old
- Both male and female
- Ethmoid disease on CT scan
- At least one non-ethmoid sinus requiring treatment
- Failed medical management and symptomatic
Key exclusion criteria (9 listed)
- Previous ethmoid surgery
- Not sufficient room for placement of Spacer
- Patient requires septoplasty
- Has received steroid treatment with in 2 weeks
- Extensive sinonasal osteoneogenesis preventing 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 |
|---|---|---|
| Ethmoid Sinus SpacerAlso: Acclarent Ethmoid Sinus Spacer and Access SystemEthmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40 | Device | Ethmoid Sinus Spacer placement |
Primary outcome
Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant
Time frame: Procedural and 6 weeks post-implant
1 secondary outcome
Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures
Time frame: 1 wk, 2wk, 4wk, 6wk
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.
- Individual participant dataSharing planned: No
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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.
Fred Kuhn, MD principal investigator
Georgia Nasal and Sinus Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethmoid Sinus Spacer in people with Sinusitis, Chronic Rhinosinusitis, 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 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 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 24 Feb 2010). 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?
Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant (time frame: Procedural and 6 weeks post-implant). 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.