Trial Outcomes & Findings for Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study (NCT NCT02952313)

NCT ID: NCT02952313

Last Updated: 2020-09-01

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 113 participants
• Primary outcome timeframe: 6 months post procedure
• Results posted on: 2020-09-01

Participant Flow

Participant milestones

Measure	Latera Implant All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Primary Endpoint STARTED	113
Primary Endpoint 6 Months	106
Primary Endpoint COMPLETED	106
Primary Endpoint NOT COMPLETED	7
Long-term Follow-up STARTED	107
Long-term Follow-up 12-Month	93
Long-term Follow-up 18-Month	79
Long-term Follow-up COMPLETED	75
Long-term Follow-up NOT COMPLETED	32

Reasons for withdrawal

Measure	Latera Implant All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Primary Endpoint Lost to Follow-up	4
Primary Endpoint Withdrawal by Subject	1
Primary Endpoint Lack of Efficacy	1
Primary Endpoint Missed visit	1
Long-term Follow-up Lost to Follow-up	12
Long-term Follow-up Did not reconsent for long-term FU	7
Long-term Follow-up Lack of Efficacy	6
Long-term Follow-up Withdrawal by Subject	5
Long-term Follow-up Physician Decision	1
Long-term Follow-up Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Latera Implant n=113 Participants All participants have unilateral or bilateral placement of LATERA Nasal Implants. Nasal Implant
Age, Continuous	45.3 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Non-Hispanic or Latino	102 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	10 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Unspecified	1 Participants n=5 Participants
Region of Enrollment United States	113 Participants n=5 Participants
NOSE Score (100-point scale)	78.5 units on a scale STANDARD_DEVIATION 13.8 • n=5 Participants
NOSE Severity Classification Severe (NOSE Scores of 55-75)	56 Participants n=5 Participants
NOSE Severity Classification Extreme (Nose Scores of 80-100	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post procedure

Population: All participants with 6-month NOSE scores

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).

Outcome measures

Measure	Latera Implant n=106 Participants All participants have unilateral or bilateral placement of LATERA Nasal Implants.
The Primary Efficacy Endpoint is the Percent of Treatment Responders	101 Participants

PRIMARY outcome

Timeframe: 6 months post procedure

Number of participants with a device-related or procedure-related adverse event

Outcome measures

Measure	Latera Implant n=113 Participants All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events	10 Participants

SECONDARY outcome

Timeframe: 1, 3 12, 18, and 24 months post procedure.

Population: All participants with NOSE scores at the applicable visit.

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).

Outcome measures

Measure	Latera Implant n=112 Participants All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Percent of Treatment Responders 1-Month FU	104 Participants
Percent of Treatment Responders 3-Month FU	106 Participants
Percent of Treatment Responders 12-Month FU	88 Participants
Percent of Treatment Responders 18-Month FU	70 Participants
Percent of Treatment Responders 24-Month FU	72 Participants

SECONDARY outcome

Timeframe: 1, 3, 6, 12, 18, and 24 months post procedure

Population: All participants with VAS scores at the applicable visit.

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.

Outcome measures

Measure	Latera Implant n=112 Participants All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). 1-Month FU	-40.4 score on a scale Interval -44.4 to -36.4
Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). 3-Month FU	-46.3 score on a scale Interval -50.3 to -42.3
Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). 6-Month FU	-45.6 score on a scale Interval -49.7 to -41.5
Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). 12-Month FU	-47.5 score on a scale Interval -51.9 to -43.1
Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). 18-Month FU	-48.7 score on a scale Interval -53.6 to -43.8
Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). 24-Month FU	-51.0 score on a scale Interval -55.9 to -46.2

SECONDARY outcome

Timeframe: 6 months

Population: All participants with satisfaction questionnaires completed at the 6-month follow-up.

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=105 Participants All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Subject Satisfaction Questionnaire	89 Participants

SECONDARY outcome

Timeframe: After 6 months and up to 24 months post procedure

Population: All participants with follow-up beyond 6 months.

Number of participants who experience procedure or device-related adverse events.

Outcome measures

Measure	Latera Implant n=106 Participants All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Procedure and Device Related Adverse Events	1 Participants

Adverse Events

Latera Implant

Serious events: 2 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Measure	Latera Implant n=113 participants at risk All participants with unilateral or bilateral placement of LATERA Nasal Implants.
Gastrointestinal disorders Gastrointestinal bleed	0.88% 1/113 • Number of events 1 • 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.
Cardiac disorders Heart valve disease	0.88% 1/113 • Number of events 1 • 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.

Other adverse events

Measure	Latera Implant n=113 participants at risk All participants with unilateral or bilateral placement of LATERA Nasal Implants.
Infections and infestations Sinusitis	11.5% 13/113 • Number of events 16 • 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.
Surgical and medical procedures Implant retrieval/extrusion	6.2% 7/113 • Number of events 7 • 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.

Additional Information

Principal Clinical Research & Publications Manager

Stryker ENT

Phone: 763-463-1598

Email: ellen.omalley@stryker.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER