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This study is being conducted to obtain outcomes data in subjects with severe to extreme class NOSE scores undergoing placement of the Spirox Latera Implant with or without concurrent septoplasty and/or turbinate reduction procedures in an operating room setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latera Implant | Other | All participants have unilateral or bilateral placement of LATERA Nasal Implants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Implant | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Endpoint is the Percent of Treatment Responders | Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100). | 6 months post procedure |
| Primary Safety Endpoint: Nasal Procedure and Lateraâ„¢ Device-related Adverse Events | Number of participants with a device-related or procedure-related adverse event | 6 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Treatment Responders | Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100). | 1, 3 12, 18, and 24 months post procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills Aesthetic Surgical Institute | Beverly Hills | California | 90210 | United States | ||
| ENT Assoc. of South Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29756407 | Result | Stolovitzky P, Sidle DM, Ow RA, Nachlas NE, Most SP. A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant. Laryngoscope. 2018 Nov;128(11):2483-2489. doi: 10.1002/lary.27242. Epub 2018 May 14. | |
| 33853139 | Derived | Sidle DM, Stolovitzky P, O'Malley EM, Ow RA, Nachlas NE, Silvers S. Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures. Facial Plast Surg. 2021 Oct;37(5):673-680. doi: 10.1055/s-0041-1726464. Epub 2021 Apr 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Latera Implant | All participants have unilateral or bilateral placement of LATERA Nasal Implants. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Endpoint |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2017 | Feb 28, 2019 |
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| Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). | Change from baseline in VAS score for ability to breathe through the nose. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (unable to breathe through the nose). Negative values for the change from baseline indicate improvement in symptoms. | 1, 3, 6, 12, 18, and 24 months post procedure |
| Subject Satisfaction Questionnaire | Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported. | 6 months |
| Procedure and Device Related Adverse Events | Number of participants who experience procedure or device-related adverse events. | After 6 months and up to 24 months post procedure |
| Boca Raton |
| Florida |
| 33487 |
| United States |
| The Center for Sinus, Allergy & Sleep Wellness | Boynton Beach | Florida | 33472 | United States |
| ENT of Georgia | Atlanta | Georgia | 30342 | United States |
| Chicago Nasal & Sinus Center | Chicago | Illinois | 60602 | United States |
| Northwestern University | Chicago | Illinois | 606611 | United States |
| ENT New Orelans | Marrero | Louisiana | 70072 | United States |
| Madison ENT & Facial Plastic Surgery | New York | New York | 10016 | United States |
| Piedmont ENT | Winston-Salem | North Carolina | 27103 | United States |
| ENT & Allergy Center of Austin | Austin | Texas | 78746 | United States |
| Collin County ENT | Frisco | Texas | 75034 | United States |
| Ogden Clinic | Ogden | Utah | 84403 | United States |
| 6 Months |
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| COMPLETED |
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| NOT COMPLETED |
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| Long-term Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Latera Implant | All participants have unilateral or bilateral placement of LATERA Nasal Implants. Nasal Implant |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| NOSE Score (100-point scale) | Nasal Obstruction Symptom Evaluation (NOSE) scale quantifies symptom severity of nasal obstruction. The tool is comprised of 5 questions (nasal congestion, nasal obstruction, trouble nose breathing, trouble sleeping, and difficulty breathing during exercise or exertion) that are rated from 0 (no problem) to 4 (severe problem). The scores for each item are summed, multiplied by 5, and reported on a 100-point scale. Scores of 5 to 25 indicate mild, 30-50 moderate, 55-75 severe, and 80-100 extreme symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| NOSE Severity Classification | Count of Participants | Participants |
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| 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 | The Primary Efficacy Endpoint is the Percent of Treatment Responders | Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100). | All participants with 6-month NOSE scores | Posted | Count of Participants | Participants | 6 months post procedure |
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| Primary | Primary Safety Endpoint: Nasal Procedure and Lateraâ„¢ Device-related Adverse Events | Number of participants with a device-related or procedure-related adverse event | Posted | Count of Participants | Participants | 6 months post procedure |
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| Secondary | Percent of Treatment Responders | Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100). | All participants with NOSE scores at the applicable visit. | Posted | Count of Participants | Participants | 1, 3 12, 18, and 24 months post procedure. |
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| Secondary | Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). | Change from baseline in VAS score for ability to breathe through the nose. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (unable to breathe through the nose). Negative values for the change from baseline indicate improvement in symptoms. | All participants with VAS scores at the applicable visit. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 1, 3, 6, 12, 18, and 24 months post procedure |
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| Secondary | Subject Satisfaction Questionnaire | Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported. | All participants with satisfaction questionnaires completed at the 6-month follow-up. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Procedure and Device Related Adverse Events | Number of participants who experience procedure or device-related adverse events. | All participants with follow-up beyond 6 months. | Posted | Count of Participants | Participants | After 6 months and up to 24 months post procedure |
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Adverse events for the primary safety endpoint are reported for the 6-month period after the study procedure.
Adverse events were systematically collected completion of standardized case report forms.
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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 | Latera Implant | All participants with unilateral or bilateral placement of LATERA Nasal Implants. | 1 | 113 | 2 | 113 | 19 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal bleed | Gastrointestinal disorders | Systematic Assessment | Patient experienced a GI bleed 3 months after the implant procedure. Unrelated to implant or procedure. |
| |
| Heart valve disease | Cardiac disorders | Systematic Assessment | Pre-existing cardiac disorder with worsening symptoms requiring surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | Systematic Assessment |
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| Implant retrieval/extrusion | Surgical and medical procedures | Systematic Assessment |
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Additional publications are restricted to after publication of the multicenter study results. The only other restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Clinical Research & Publications Manager | Stryker ENT | 763-463-1598 | ellen.omalley@stryker.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 3, 2018 | Mar 7, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
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| Withdrawal by Subject |
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| Physician Decision |
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| Death |
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| Unspecified |
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