Trial Outcomes & Findings for LATERA-OFFICE Study (NCT NCT02964312)
NCT ID: NCT02964312
Last Updated: 2020-09-03
Results Overview
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
COMPLETED
NA
166 participants
6 months
2020-09-03
Participant Flow
Participant milestones
| Measure |
Latera Implant
Nasal Implant
Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure
|
|---|---|
|
Overall Study
STARTED
|
166
|
|
Overall Study
1-Month Follow-up
|
164
|
|
Overall Study
3-Month Follow-up
|
159
|
|
Overall Study
6-Month Follow-up
|
152
|
|
Overall Study
12-Month Follow-up
|
139
|
|
Overall Study
18-Month Follow-up
|
112
|
|
Overall Study
24-Month Follow-up
|
102
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
Latera Implant
Nasal Implant
Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure
|
|---|---|
|
Overall Study
Lost to Follow-up
|
28
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Lack of Efficacy
|
10
|
|
Overall Study
Did not consent to long-term FU
|
14
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
LATERA-OFFICE Study
Baseline characteristics by cohort
| Measure |
Latera Implant
n=166 Participants
Nasal Implant
Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure
|
|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not Specified
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
166 participants
n=5 Participants
|
|
NOSE score (100-point scale)
|
77.4 units on a scale
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Nose Severity Class
Severe
|
90 Participants
n=5 Participants
|
|
Nose Severity Class
Extreme
|
76 Participants
n=5 Participants
|
|
Nasal Obstruction Visual Analog Scale (VAS)
|
68.0 units on a scale
STANDARD_DEVIATION 18.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants who had placement of 1 or more Latera implants and had a 6-month NOSE score.
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Outcome measures
| Measure |
Latera Implant
n=152 Participants
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure.
|
|---|---|
|
Efficacy: Percent of Treatment Responders
|
136 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants who received 1 or more Latera implants.
Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.
Outcome measures
| Measure |
Latera Implant
n=166 Participants
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure.
|
|---|---|
|
Safety: Procedure- and/or Device-related Adverse Events
|
31 Participants
|
SECONDARY outcome
Timeframe: 1, 3, 12, 18, and 24 months post procedure.Population: All participants with NOSE scores at the applicable visit.
A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).
Outcome measures
| Measure |
Latera Implant
n=164 Participants
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure.
|
|---|---|
|
Percent of Treatment Responders
1-Month Follow-up
|
147 Participants
|
|
Percent of Treatment Responders
3-Month Follow-up
|
143 Participants
|
|
Percent of Treatment Responders
12-Month Follow-up
|
124 Participants
|
|
Percent of Treatment Responders
18-Month Follow-up
|
103 Participants
|
|
Percent of Treatment Responders
24-Month Follow-up
|
93 Participants
|
SECONDARY outcome
Timeframe: 1, 3, 6, 12, 18, and 24 months post procedurePopulation: All participants with VAS scores at the applicable visit.
Change from baseline in the nasal obstryction VAS score. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (difficult to breathe through the nose) using a 100-mm line with 1-mm increments). Negative values indicate improvement in symptoms.
Outcome measures
| Measure |
Latera Implant
n=164 Participants
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure.
|
|---|---|
|
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
1-Month Follow-up
|
-34.3 score on a scale
Standard Deviation 27.0
|
|
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
3-Month Follow-up
|
-35.5 score on a scale
Standard Deviation 28.5
|
|
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
6-Month Follow-up
|
-36.9 score on a scale
Standard Deviation 29.0
|
|
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
12-Month Follow-up
|
-37.9 score on a scale
Standard Deviation 29.8
|
|
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
18-Month Follow-up
|
-41.5 score on a scale
Standard Deviation 27.3
|
|
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
24-Month Follow-up
|
-41.7 score on a scale
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants who completed a satisfaction questionnaire at the 6-month visit.
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.
Outcome measures
| Measure |
Latera Implant
n=149 Participants
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure.
|
|---|---|
|
Subject Satisfaction Questionnaire
|
115 Participants
|
SECONDARY outcome
Timeframe: After 6 months and up to 12 months post procedurePopulation: All participants with greater than 6-months follow-up.
Number of participants who experience procedure- or device-related adverse events.
Outcome measures
| Measure |
Latera Implant
n=139 Participants
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure.
|
|---|---|
|
Procedure and Device-related Adverse Events
|
3 Participants
|
Adverse Events
Latera Implant
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Latera Implant
n=166 participants at risk
Nasal Implant
Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure
|
|---|---|
|
Surgical and medical procedures
Implant migration/retrieval
|
9.0%
15/166 • Number of events 16 • 24 months post procedure
Participants were queried about possible adverse events at each follow-up visit. Adverse event data were collected on standardized case report forms.
|
|
Infections and infestations
Sinus infection
|
6.0%
10/166 • Number of events 10 • 24 months post procedure
Participants were queried about possible adverse events at each follow-up visit. Adverse event data were collected on standardized case report forms.
|
Additional Information
Principal Clinical Research & Publications Manager
Stryker ENT
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60