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Interim assessment performed after 14 patients provided evidence that further enrollment was not required to achieve intended endpoints of the study.
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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethmoid Sinus Spacer placement | Experimental | Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethmoid Sinus Spacer | Device | Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant | Procedural and 6 weeks post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures | 1 wk, 2wk, 4wk, 6wk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fred Kuhn, MD | Georgia Nasal and Sinus Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Nasal and Sinus Institute | Savannah | Georgia | 31404 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ethmoid Sinus Spacer Placement | Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ethmoid Sinus Spacer Placement | Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant | Posted | Number | participants | Procedural and 6 weeks post-implant |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ethmoid Sinus Spacer Placement | Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epistaxis | Skin and subcutaneous tissue disorders | SNOMED | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura England, Manager-Clinical Research | Acclarent | 650-687-4466 | lenglan1@its.jnj.com |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures | Not Posted | 1 wk, 2wk, 4wk, 6wk | Participants |
| 0 |
| 14 |
| 1 |
| 14 |
Principal investigator shall not issue or disseminate any press release or statement, nor initiate or cause to be initiated any communication of information regarding the clinical trial (written or oral) to the communications media or third parties without the prior written consent of Sponsor.
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |