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| Name | Class |
|---|---|
| New Arch Consulting | INDUSTRY |
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The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera Implant to improve nasal breathing, compared with a Sham Control procedure.
To evaluate the Latera Absorbable Nasal Implant (Latera Implant) Implant versus Sham Control in subjects with nasal valve collapse due to or primarily due to insufficient cartilaginous support of the lateral nasal wall.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Control Arm | Sham Comparator | Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed. Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study. |
|
| Latera Treatment Arm | Experimental | Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latera Implant | Device | Treatment with implant |
| |
| Sham Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| NOSE Responder Rate | The primary endpoint of the study is the NOSE Responder Rate, assessed 3 months post-procedure in the per-protocol population of the Latera and Sham arms. The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. NOSE scores can also be categorized as mild (5-25), moderate (30-50), severe (55-75), and extreme (80-100). A NOSE responder is defined as a participant with at least 1 NOSE class improvement or at least 20% total NOSE score reduction. | 3 months postprocedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate | Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed | 7 days, 30 days, and 6, 12, 18 and 24 months. |
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Subjects must meet the following criteria to be included in the study:
Subjects meeting any one of the following criteria will be excluded for the study:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Stolovitzky, MD | ENT of Georgia | Principal Investigator |
| Douglas Sidle, MD | Northwestern Facial Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento ENT | Roseville | California | 95661 | United States | ||
| Breathe Clear Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31226238 | Result | Stolovitzky P, Senior B, Ow RA, Mehendale N, Bikhazi N, Sidle DM. Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. Int Forum Allergy Rhinol. 2019 Aug;9(8):850-856. doi: 10.1002/alr.22362. Epub 2019 Jun 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Control Arm | Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed. Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study. Latera Implant: Treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 23, 2018 | Nov 25, 2019 |
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Sham procedure participants will be allowed to crossover to receive Latera implants after the 3-month assessment if they continue to meet eligibility criteria. Crossover participants will be followed through 24 months post implant. Sham participants who do not crossover will be exited after the 3-month assessment.
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Participants will be masked to treatment assignment through the 3-month assessment period.
| Device |
Sham procedure where the Latera delivery device is inserted but no implant delivered. |
|
| Torrance |
| California |
| 90503 |
| United States |
| ENT of GA | Atlanta | Georgia | 30342 | United States |
| Chicago Nasal and Sinus Center | Chicago | Illinois | 60602 | United States |
| Michiana Sleep and ENT Solutions | South Bend | Indiana | 46635 | United States |
| Albany ENT & Allergy | Albany | New York | 12206 | United States |
| Piedmont ENT | Winston-Salem | North Carolina | 27103 | United States |
| Texas ENT Specialist | Houston | Texas | 77094 | United States |
| ENT Associates of Texas | McKinney | Texas | 78209 | United States |
| Texas Facial Plastics and ENT | San Antonio | Texas | 78239 | United States |
| Ogden Clinic | Ogden | Utah | 84403 | United States |
| FG001 | Latera Treatment Arm | Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant. Latera Implant: Treatment |
| 3-Month Follow-up | 1 participant randomized to sham inadvertently received an implant and was analyzed as treated. |
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| COMPLETED |
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| NOT COMPLETED |
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Participants with evaluable data for the primary endpoint at 3-month follow-up
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Control Arm | Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed. Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study. Latera Implant: Treatment |
| BG001 | Latera Treatment Arm | Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant. Latera Implant: Treatment |
| BG002 | Total | Total of all reporting groups |
| 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 (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline Nasal Obstruction Symptom Evaluation (NOSE) Score | The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. | Mean | Standard Deviation | units on a scale |
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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 | NOSE Responder Rate | The primary endpoint of the study is the NOSE Responder Rate, assessed 3 months post-procedure in the per-protocol population of the Latera and Sham arms. The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. NOSE scores can also be categorized as mild (5-25), moderate (30-50), severe (55-75), and extreme (80-100). A NOSE responder is defined as a participant with at least 1 NOSE class improvement or at least 20% total NOSE score reduction. | Posted | Count of Participants | Participants | 3 months postprocedure. |
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| Secondary | Responder Rate | Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed | Not Posted | 7 days, 30 days, and 6, 12, 18 and 24 months. | Participants |
Adverse events reported from procedure through 3-month follow-up.
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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 | Sham Control Arm | Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed. Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study. Latera Implant: Treatment | 1 | 64 | 2 | 64 | 0 | 64 |
| EG001 | Latera Treatment Arm | Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant. Latera Implant: Treatment | 0 | 63 | 3 | 63 | 5 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver cancer | Hepatobiliary disorders | Systematic Assessment | Not related to study device or procedure |
| |
| Degenerative disc disease/stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to study device or procedure |
| |
| Death | General disorders | Systematic Assessment | Unknown cause of death. Not related to study device or procedure |
| |
| Severe hypertension | General disorders | Systematic Assessment | Not related to study device or procedure |
| |
| Orthopedic surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment | Right knee surgery. Not related to study device or procedure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant extrusion/migration | Product Issues | Systematic Assessment |
|
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| 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 | Feb 12, 2018 | Nov 25, 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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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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