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

• Sponsor: Spirox, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02952313
• Collaborator: (none)
• Enrollment: 113
• Locations: 12
• Arm: 1
• Actual Duration (Months): 35
• Patients Per Site: 9.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study is being conducted to obtain outcomes data in subjects with severe to extreme class NOSE scores undergoing placement of the Spirox Latera Implant with or without concurrent septoplasty and/or turbinate reduction procedures in an operating room setting.

Condition or Disease	Intervention/Treatment	Phase
Nasal Obstruction	Device: Nasal Implant	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 113 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Latera Implant All participants have unilateral or bilateral placement of LATERA Nasal Implants.	Device: Nasal Implant

Outcome Measures

Primary Outcome Measures

1. The Primary Efficacy Endpoint is the Percent of Treatment Responders [6 months post procedure]

   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).

2. Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events [6 months post procedure]

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

Secondary Outcome Measures

1. Percent of Treatment Responders [1, 3 12, 18, and 24 months post procedure.]

   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).

2. Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). [1, 3, 6, 12, 18, and 24 months post procedure]

   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.

3. Subject Satisfaction Questionnaire [6 months]

   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.

4. Procedure and Device Related Adverse Events [After 6 months and up to 24 months post procedure]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The subject has Nasal Obstruction Symptom Evaluation (NOSE) Score ≥55.

2. The subject has dynamic lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver22.

3. The subject is ≥18 years of age.

4. The subject is willing and able to provide informed consent and comply with the study protocol.

5. The subject is seeking treatment for nasal airway obstruction due to Nasal Valve Collapse (NVC) and is willing to undergo nasal Implant procedure alone or with septoplasty and/or a turbinate reduction procedure in an operating room setting.

6. The subject has appropriate nasal and facial anatomy to receive Latera Implant.

7. The subject agrees to follow-up examinations through twelve (12) months post operatively.

8. The subject has failed a trial of appropriate maximal medical management [e.g., nasal steroids (at least 4 weeks); antihistamines; oral decongestants; nasal strips, stents, or cones]. Failure of maximal medical management may be from lack of effectiveness or inability of subject to tolerate.

Exclusion Criteria:

1. The subject is having a concurrent Functional Endoscopic Sinus Surgery (FESS) or sinuplasty.

2. The subject has had rhinoplasty within the past twelve (12) months.

3. The subject is planning to have other concurrent rhinoplasty procedure.

4. The subject is planning to have other rhinoplasty procedures or will use external dilators within twelve (12) months after the index procedure.

5. The subject has had septoplasty and/or inferior turbinate reduction within the past six (6) months.

6. The subject has, in the view of the clinician, inappropriate fixation on their nasal airway.

7. The subject plans to have any surgical or non-surgical treatment of their nasal valve, other than the index procedure, within twelve (12) months of the study.

8. The subject has a permanent Implant or dilator in the nasal area.

9. The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area.

10. The subject currently has active nasal vestibulitis.

11. The subject has a history of nasal vasculitis.

12. The subject is a chronic systemic steroid or recreational intra-nasal drug user.

13. The subject has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.

14. The subject has polyps or pathology other than septal deviation and/or turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction.

15. The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure.

16. The subject has a known or suspected allergy to poly lactic acid (PLA) or other absorbable materials.

17. The subject has a significant systemic disease such as poorly controlled diabetes which, in the investigator's opinion, could pre-dispose the subject to poor wound healing.

18. The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).

19. The subject is not a candidate for procedures conducted under general anesthesia, managed anesthesia care (MAC) or conscious sedation.

20. If female, subject is known or suspected to be pregnant or is lactating.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beverly Hills Aesthetic Surgical Institute	Beverly Hills	California	United States	90210
2	ENT Assoc. of South Florida	Boca Raton	Florida	United States	33487
3	The Center for Sinus, Allergy & Sleep Wellness	Boynton Beach	Florida	United States	33472
4	ENT of Georgia	Atlanta	Georgia	United States	30342
5	Chicago Nasal & Sinus Center	Chicago	Illinois	United States	60602
6	Northwestern University	Chicago	Illinois	United States	606611
7	ENT New Orelans	Marrero	Louisiana	United States	70072
8	Madison ENT & Facial Plastic Surgery	New York	New York	United States	10016
9	Piedmont ENT	Winston-Salem	North Carolina	United States	27103
10	ENT & Allergy Center of Austin	Austin	Texas	United States	78746
11	Collin County ENT	Frisco	Texas	United States	75034
12	Ogden Clinic	Ogden	Utah	United States	84403

Sponsors and Collaborators

• Spirox, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Sep 7, 2017
• Statistical Analysis Plan - Jan 3, 2018

More Information

Publications

None provided.

• Responsible Party: Spirox, Inc.
• ClinicalTrials.gov Identifier: NCT02952313
• Other Study ID Numbers: SPI-CP-301
• First Posted: Nov 2, 2016
• Last Update Posted: Sep 1, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Nasal Obstruction

Study Results

Participant Flow

Arm/Group Title	Latera Implant
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
Period Title: Primary Endpoint
STARTED	107
12-Month	93
18-Month	79
COMPLETED	75
NOT COMPLETED	32

Baseline Characteristics

Arm/Group Title	Latera Implant
Arm/Group Description	All participants have unilateral or bilateral placement of LATERA Nasal Implants. Nasal Implant
Overall Participants	113
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.3 (13.7)
Sex: Female, Male (Count of Participants)
Female	49 43.4%
Male	64 56.6%
Race/Ethnicity, Customized (Count of Participants)
Non-Hispanic or Latino	102 90.3%
Hispanic or Latino	10 8.8%
Unspecified	1 0.9%
Region of Enrollment (Count of Participants)
United States	113 100%
NOSE Score (100-point scale) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	78.5 (13.8)
NOSE Severity Classification (Count of Participants)
Severe (NOSE Scores of 55-75)	56 49.6%
Extreme (Nose Scores of 80-100	57 50.4%

Outcome Measures

1. Primary Outcome

Title	The Primary Efficacy Endpoint is the Percent of Treatment Responders
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

Outcome Measure Data

Analysis Population Description

All participants with 6-month NOSE scores

Arm/Group Title	Latera Implant
Arm/Group Description	All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Measure Participants	106
Count of Participants [Participants]	101 89.4%

2. Primary Outcome

Title	Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events
Description	Number of participants with a device-related or procedure-related adverse event
Time Frame	6 months post procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Latera Implant
Arm/Group Description	All participants with unilateral or bilateral placement of LATERA Nasal Implants.
Measure Participants	113
Count of Participants [Participants]	10 8.8%

3. Secondary Outcome

Title	Percent of Treatment Responders
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.

Outcome Measure Data

Analysis Population Description

All participants with NOSE scores at the applicable visit.

Arm/Group Title	Latera Implant
Arm/Group Description	All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Measure Participants	112
1-Month FU	104 92%
3-Month FU	106 93.8%
12-Month FU	88 77.9%
18-Month FU	70 61.9%
24-Month FU	72 63.7%

4. Secondary Outcome

Title	Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).
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

Outcome Measure Data

Analysis Population Description

All participants with VAS scores at the applicable visit.

Arm/Group Title	Latera Implant
Arm/Group Description	All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Measure Participants	112
1-Month FU	-40.4
3-Month FU	-46.3
6-Month FU	-45.6
12-Month FU	-47.5
18-Month FU	-48.7
24-Month FU	-51.0

5. Secondary Outcome

Title	Subject Satisfaction Questionnaire
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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Latera Implant
Arm/Group Description	All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Measure Participants	105
Count of Participants [Participants]	89 78.8%

6. Secondary Outcome

Title	Procedure and Device Related Adverse Events
Description	Number of participants who experience procedure or device-related adverse events.
Time Frame	After 6 months and up to 24 months post procedure

Outcome Measure Data

Analysis Population Description

All participants with follow-up beyond 6 months.

Arm/Group Title	Latera Implant
Arm/Group Description	All participants with unilateral or bilateral placement of LATERA Nasal Implants.
Measure Participants	106
Count of Participants [Participants]	1 0.9%

Adverse Events

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
Arm/Group Description	All participants with unilateral or bilateral placement of LATERA Nasal Implants.
All Cause Mortality
	Latera Implant
	Affected / at Risk (%)	# Events
Total	1/113 (0.9%)
Serious Adverse Events
	Latera Implant
	Affected / at Risk (%)	# Events
Total	2/113 (1.8%)
Cardiac disorders
Heart valve disease	1/113 (0.9%)	1
Gastrointestinal disorders
Gastrointestinal bleed	1/113 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Latera Implant
	Affected / at Risk (%)	# Events
Total	19/113 (16.8%)
Infections and infestations
Sinusitis	13/113 (11.5%)	16
Surgical and medical procedures
Implant retrieval/extrusion	7/113 (6.2%)	7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.