Trial Outcomes & Findings for Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse (NCT NCT03400787)
NCT ID: NCT03400787
Last Updated: 2021-02-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
137 participants
Primary outcome timeframe
3 months postprocedure.
Results posted on
2021-02-09
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
71
|
|
Overall Study
3-Month Follow-up
|
64
|
63
|
|
Overall Study
COMPLETED
|
64
|
63
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Unblinded before 3-month follow-upa-
|
0
|
6
|
Baseline Characteristics
Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse
Baseline characteristics by cohort
| Measure |
Sham Control Arm
n=64 Participants
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
|
Latera Treatment Arm
n=63 Participants
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
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 13.5 • n=99 Participants
|
50.9 years
STANDARD_DEVIATION 14.2 • n=107 Participants
|
51.1 years
STANDARD_DEVIATION 13.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=99 Participants
|
63 participants
n=107 Participants
|
127 participants
n=206 Participants
|
|
Baseline Nasal Obstruction Symptom Evaluation (NOSE) Score
|
77.7 units on a scale
STANDARD_DEVIATION 15.1 • n=99 Participants
|
77.4 units on a scale
STANDARD_DEVIATION 13.1 • n=107 Participants
|
77.6 units on a scale
STANDARD_DEVIATION 14.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 months postprocedure.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.
Outcome measures
| Measure |
Sham Control Arm
n=64 Participants
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
|
Latera Treatment Arm
n=63 Participants
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
|
|---|---|---|
|
NOSE Responder Rate
|
35 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: 7 days, 30 days, and 6, 12, 18 and 24 months.Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed
Outcome measures
Outcome data not reported
Adverse Events
Sham Control Arm
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Latera Treatment Arm
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham Control Arm
n=64 participants at risk
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
|
Latera Treatment Arm
n=63 participants at risk
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
|
|---|---|---|
|
Hepatobiliary disorders
Liver cancer
|
0.00%
0/64 • Adverse events reported from procedure through 3-month follow-up.
|
1.6%
1/63 • Number of events 1 • Adverse events reported from procedure through 3-month follow-up.
|
|
Musculoskeletal and connective tissue disorders
Degenerative disc disease/stenosis
|
0.00%
0/64 • Adverse events reported from procedure through 3-month follow-up.
|
1.6%
1/63 • Number of events 1 • Adverse events reported from procedure through 3-month follow-up.
|
|
General disorders
Death
|
1.6%
1/64 • Number of events 1 • Adverse events reported from procedure through 3-month follow-up.
|
0.00%
0/63 • Adverse events reported from procedure through 3-month follow-up.
|
|
General disorders
Severe hypertension
|
0.00%
0/64 • Adverse events reported from procedure through 3-month follow-up.
|
1.6%
1/63 • Number of events 1 • Adverse events reported from procedure through 3-month follow-up.
|
|
Musculoskeletal and connective tissue disorders
Orthopedic surgery
|
1.6%
1/64 • Number of events 1 • Adverse events reported from procedure through 3-month follow-up.
|
0.00%
0/63 • Adverse events reported from procedure through 3-month follow-up.
|
Other adverse events
| Measure |
Sham Control Arm
n=64 participants at risk
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
|
Latera Treatment Arm
n=63 participants at risk
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
|
|---|---|---|
|
Product Issues
Implant extrusion/migration
|
0.00%
0/64 • Adverse events reported from procedure through 3-month follow-up.
|
7.9%
5/63 • Number of events 5 • Adverse events reported from procedure through 3-month follow-up.
|
Additional Information
Principal Clinical Research & Publications Manager
Stryker ENT
Phone: 763-463-1598
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60