Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952313
Recruitment Status : Completed
First Posted : November 2, 2016
Results First Posted : April 23, 2019
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Spirox, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Nasal Obstruction
Intervention Device: Nasal Implant
Enrollment 113
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Latera Implant
Hide Arm/Group Description All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Period Title: Primary Endpoint
Started 113
6 Months 106
Completed 106
Not Completed 7
Reason Not Completed
Lost to Follow-up             4
Withdrawal by Subject             1
Lack of Efficacy             1
Missed visit             1
Period Title: Long-term Follow-up
Started [1] 107
12-Month 93
18-Month 79
Completed 75
Not Completed 32
Reason Not Completed
Lost to Follow-up             12
Did not reconsent for long-term FU             7
Lack of Efficacy             6
Withdrawal by Subject             5
Physician Decision             1
Death             1
[1]
Participant with missed 6-month visit (primary endpoint) was included in later follow-up.
Arm/Group Title Latera Implant
Hide Arm/Group Description

All participants have unilateral or bilateral placement of LATERA Nasal Implants.

Nasal Implant

Overall Number of Baseline Participants 113
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants
45.3  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants
Female
49
  43.4%
Male
64
  56.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 113 participants
Non-Hispanic or Latino
102
  90.3%
Hispanic or Latino
10
   8.8%
Unspecified
1
   0.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 113 participants
113
 100.0%
NOSE Score (100-point scale)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 113 participants
78.5  (13.8)
[1]
Measure Description: 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.
NOSE Severity Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants
Severe (NOSE Scores of 55-75)
56
  49.6%
Extreme (Nose Scores of 80-100
57
  50.4%
1.Primary Outcome
Title The Primary Efficacy Endpoint is the Percent of Treatment Responders
Hide Description 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).
Time Frame 6 months post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with 6-month NOSE scores
Arm/Group Title Latera Implant
Hide Arm/Group Description:
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Overall Number of Participants Analyzed 106
Measure Type: Count of Participants
Unit of Measure: Participants
101
  95.3%
2.Primary Outcome
Title Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events
Hide Description Number of participants with a device-related or procedure-related adverse event
Time Frame 6 months post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Latera Implant
Hide Arm/Group Description:
All participants with unilateral or bilateral placement of LATERA Nasal Implants.
Overall Number of Participants Analyzed 113
Measure Type: Count of Participants
Unit of Measure: Participants
10
   8.8%
3.Secondary Outcome
Title Percent of Treatment Responders
Hide Description 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).
Time Frame 1, 3 12, 18, and 24 months post procedure.
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with NOSE scores at the applicable visit.
Arm/Group Title Latera Implant
Hide Arm/Group Description:
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Overall Number of Participants Analyzed 112
Measure Type: Count of Participants
Unit of Measure: Participants
1-Month FU Number Analyzed 112 participants
104
  92.9%
3-Month FU Number Analyzed 111 participants
106
  95.5%
12-Month FU Number Analyzed 93 participants
88
  94.6%
18-Month FU Number Analyzed 73 participants
70
  95.9%
24-Month FU Number Analyzed 75 participants
72
  96.0%
4.Secondary Outcome
Title Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).
Hide Description 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.
Time Frame 1, 3, 6, 12, 18, and 24 months post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with VAS scores at the applicable visit.
Arm/Group Title Latera Implant
Hide Arm/Group Description:
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Overall Number of Participants Analyzed 112
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
1-Month FU Number Analyzed 112 participants
-40.4
(-44.4 to -36.4)
3-Month FU Number Analyzed 111 participants
-46.3
(-50.3 to -42.3)
6-Month FU Number Analyzed 105 participants
-45.6
(-49.7 to -41.5)
12-Month FU Number Analyzed 93 participants
-47.5
(-51.9 to -43.1)
18-Month FU Number Analyzed 73 participants
-48.7
(-53.6 to -43.8)
24-Month FU Number Analyzed 75 participants
-51.0
(-55.9 to -46.2)
5.Secondary Outcome
Title Subject Satisfaction Questionnaire
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with satisfaction questionnaires completed at the 6-month follow-up.
Arm/Group Title Latera Implant
Hide Arm/Group Description:
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Overall Number of Participants Analyzed 105
Measure Type: Count of Participants
Unit of Measure: Participants
89
  84.8%
6.Secondary Outcome
Title Procedure and Device Related Adverse Events
Hide Description Number of participants who experience procedure or device-related adverse events.
Time Frame After 6 months and up to 24 months post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with follow-up beyond 6 months.
Arm/Group Title Latera Implant
Hide Arm/Group Description:
All participants with unilateral or bilateral placement of LATERA Nasal Implants.
Overall Number of Participants Analyzed 106
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.9%
Time Frame Adverse events for the primary safety endpoint are reported for the 6-month period after the study procedure.
Adverse Event Reporting Description Adverse events were systematically collected completion of standardized case report forms.
 
Arm/Group Title Latera Implant
Hide Arm/Group Description All participants with unilateral or bilateral placement of LATERA Nasal Implants.
All-Cause Mortality
Latera Implant
Affected / at Risk (%)
Total   1/113 (0.88%)    
Hide Serious Adverse Events
Latera Implant
Affected / at Risk (%) # Events
Total   2/113 (1.77%)    
Cardiac disorders   
Heart valve disease  [1]  1/113 (0.88%)  1
Gastrointestinal disorders   
Gastrointestinal bleed  [2]  1/113 (0.88%)  1
Indicates events were collected by systematic assessment
[1]
Pre-existing cardiac disorder with worsening symptoms requiring surgery.
[2]
Patient experienced a GI bleed 3 months after the implant procedure. Unrelated to implant or procedure.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Latera Implant
Affected / at Risk (%) # Events
Total   19/113 (16.81%)    
Infections and infestations   
Sinusitis   13/113 (11.50%)  16
Surgical and medical procedures   
Implant retrieval/extrusion   7/113 (6.19%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Principal Clinical Research & Publications Manager
Organization: Stryker ENT
Phone: 763-463-1598
EMail: ellen.omalley@stryker.com
Layout table for additonal information
Responsible Party: Spirox, Inc.
ClinicalTrials.gov Identifier: NCT02952313    
Other Study ID Numbers: SPI-CP-301
First Submitted: October 31, 2016
First Posted: November 2, 2016
Results First Submitted: March 7, 2019
Results First Posted: April 23, 2019
Last Update Posted: September 1, 2020