LATERA-OFFICE Study

• Sponsor: Spirox, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02964312
• Collaborator: New Arch Consulting (Other)
• Enrollment: 166
• Locations: 9
• Arm: 1
• Actual Duration (Months): 33.6
• Patients Per Site: 18.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Prospective, multicenter, nonrandomized, single-arm controlled study to obtain outcomes data in participants with severe to extreme class NOSE scores who are undergoing placement of the Spirox Latera Implant with or without concurrent turbinate reduction procedures in an office setting.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 166 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single-arm intervention with pre/post comparison for treatment response.Single-arm intervention with pre/post comparison for treatment response.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OFFICE) Study
• Actual Study Start Date: Nov 10, 2016
• Actual Primary Completion Date: Mar 21, 2018
• Actual Study Completion Date: Aug 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Latera Implant Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.	Device: Nasal Implant; Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.

Outcome Measures

Primary Outcome Measures

1. Efficacy: Percent of Treatment Responders [6 months]

   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).

2. Safety: Procedure- and/or Device-related Adverse Events [6 months]

   Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.

Secondary Outcome Measures

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

   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).

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

   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.

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 12 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 maneuver.

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 an in-office nasal implant procedure alone or with a turbinate reduction procedure.

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

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

8. The subject has failed to benefit from appropriate maximal medical management [eg, 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 tolerability.

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 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 12 months after the index procedure.

5. The subject has had septoplasty and/or inferior turbinate reduction within the past 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 nonsurgical treatment of their nasal valve, other than the index procedure, within 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 intranasal drug user.

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

14. The subject has polyps or pathology (ie, septal deviation) other than 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 polylactide polymer (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 predispose 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 local anesthesia and/or managed anesthesia care (MAC) or conscious sedation.

20. Female subjects of childbearing potential, 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	Alessi Institute For Facial Plastic Surgery	Beverly Hills	California	United States	90212
3	ENT Assoc. of South Florida	Boca Raton	Florida	United States	33487
4	The Center for Sinus, Allergy, & Sleep Wellness	Boynton Beach	Florida	United States	33472
5	ENT of Georgia	Atlanta	Georgia	United States	30342
6	Chicago Nasal & Sinus Center	Chicago	Illinois	United States	60602
7	Madison ENT & Facial Plastic Surgery	New York	New York	United States	10016
8	Collin County ENT	Frisco	Texas	United States	75034
9	Ogden Clinic	Ogden	Utah	United States	84403

Sponsors and Collaborators

• Spirox, Inc.
• New Arch Consulting

Investigators

• Principal Investigator: Douglas Sidle, MD, Northwestern University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 7, 2017

More Information

Publications

None provided.

• Responsible Party: Spirox, Inc.
• ClinicalTrials.gov Identifier: NCT02964312
• Other Study ID Numbers: SPI-CP-302
• First Posted: Nov 16, 2016
• Last Update Posted: Sep 3, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Spirox, Inc.: nasal valve collapse; absorbable nasal implant
• Additional relevant MeSH terms: Nasal Obstruction

Study Results

Participant Flow

Arm/Group Title	Latera Implant
Arm/Group Description	Nasal Implant Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure
Period Title: Overall Study
STARTED	166
1-Month Follow-up	164
3-Month Follow-up	159
6-Month Follow-up	152
12-Month Follow-up	139
18-Month Follow-up	112
24-Month Follow-up	102
COMPLETED	102
NOT COMPLETED	64

Baseline Characteristics

Arm/Group Title	Latera Implant
Arm/Group Description	Nasal Implant Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure
Overall Participants	166
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.5 (14.9)
Sex: Female, Male (Count of Participants)
Female	82 49.4%
Male	84 50.6%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	1 0.6%
Asian	3 1.8%
Black or African American	3 1.8%
Hispanic or Latino	11 6.6%
White	143 86.1%
Other	4 2.4%
Not Specified	1 0.6%
Region of Enrollment (participants) [Number]
United States	166 100%
NOSE score (100-point scale) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	77.4 (13.4)
Nose Severity Class (Count of Participants)
Severe	90 54.2%
Extreme	76 45.8%
Nasal Obstruction Visual Analog Scale (VAS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	68.0 (18.0)

Outcome Measures

1. Primary Outcome

Title	Efficacy: Percent of Treatment Responders
Description	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).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All participants who had placement of 1 or more Latera implants and had a 6-month NOSE score.

Arm/Group Title	Latera Implant
Arm/Group Description	Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure.
Measure Participants	152
Count of Participants [Participants]	136 81.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Latera Implant
	Comments	The null hypothesis was that the proportion of responders at 6 months would be 50%. Since there was not direct comparison group, the hypothesis was set as a superiority comparison to a target proportion (66%) with a power level >90%.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Proportion
	Estimated Value	89.5
	Confidence Interval	(2-Sided) 95%; 83.5 to 93.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Safety: Procedure- and/or Device-related Adverse Events
Description	Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All participants who received 1 or more Latera implants.

Arm/Group Title	Latera Implant
Arm/Group Description	Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure
Measure Participants	166
Count of Participants [Participants]	31 18.7%

3. Secondary Outcome

Title	Percent of Treatment Responders
Description	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).
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	Nasal Implant Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure
Measure Participants	164
1-Month Follow-up	147 88.6%
3-Month Follow-up	143 86.1%
12-Month Follow-up	124 74.7%
18-Month Follow-up	103 62%
24-Month Follow-up	93 56%

4. Secondary Outcome

Title	Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
Description	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.
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	Nasal Implant Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure
Measure Participants	164
1-Month Follow-up	-34.3 (27.0)
3-Month Follow-up	-35.5 (28.5)
6-Month Follow-up	-36.9 (29.0)
12-Month Follow-up	-37.9 (29.8)
18-Month Follow-up	-41.5 (27.3)
24-Month Follow-up	-41.7 (26.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Latera Implant
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	P values are based on paired t-tests for change from baseline with p<0.05 indicating significance.
	Method	t-test, 2 sided
	Comments

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 who completed a satisfaction questionnaire at the 6-month visit.

Arm/Group Title	Latera Implant
Arm/Group Description	Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage. Nasal Implant: Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.
Measure Participants	149
Count of Participants [Participants]	115 69.3%

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 12 months post procedure

Outcome Measure Data

Analysis Population Description

All participants with greater than 6-months follow-up.

Arm/Group Title	Latera Implant
Arm/Group Description	Nasal Implant Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure
Measure Participants	139
Count of Participants [Participants]	3 1.8%

Adverse Events

Time Frame	24 months post procedure
Adverse Event Reporting Description	Participants were queried about possible adverse events at each follow-up visit. Adverse event data were collected on standardized case report forms.
Arm/Group Title	Latera Implant
Arm/Group Description	Nasal Implant Nasal Implant: Latera implant will be placed in stand alone procedure or in conjunction with a turbinate reduction procedure
All Cause Mortality
	Latera Implant
	Affected / at Risk (%)	# Events
Total	1/166 (0.6%)
Serious Adverse Events
	Latera Implant
	Affected / at Risk (%)	# Events
Total	0/166 (0%)
Other (Not Including Serious) Adverse Events
	Latera Implant
	Affected / at Risk (%)	# Events
Total	24/166 (14.5%)
Infections and infestations
Sinus infection	10/166 (6%)	10
Surgical and medical procedures
Implant migration/retrieval	15/166 (9%)	16

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure 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. The sponsor cannot require changes to the communication and cannot extend the embargo.