CompletedNCT02964312Updated Sep 3, 2020Results posted

LATERA-OFFICE Study

An interventional study of Nasal Implant in Nasal Obstruction, sponsored by Spirox, Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-03.

Sponsored by Spirox, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 166
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Nasal Obstruction

Browse trials for

Nasal Obstruction 108

Keywords

nasal valve collapse
absorbable nasal implant

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

The subject has Nasal Obstruction Symptom Evaluation (NOSE) score ≥55.
The subject has dynamic lateral nasal wall insufficiency as confirmed by positive modified Cottle maneuver.
The subject is ≥18 years of age.
The subject is willing and able to provide informed consent and comply with the study protocol.
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.
The subject has appropriate nasal and facial anatomy to receive the Latera Implant.
The subject agrees to follow-up examinations through 12 months post operatively.
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

Exclusion Criteria:

The subject is having a concurrent functional endoscopic sinus surgery (FESS) or sinuplasty.
The subject has had rhinoplasty within the past 12 months.
The subject is planning to have other concurrent rhinoplasty procedure.
The subject is planning to have other rhinoplasty procedures or will use external dilators within 12 months after the index procedure.
The subject has had septoplasty and/or inferior turbinate reduction within the past 6 months.
The subject has, in the view of the clinician, inappropriate fixation on their nasal airway.
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.
The subject has a permanent Implant or dilator in the nasal area.
The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area.
The subject currently has active nasal vestibulitis.
The subject has a history of nasal vasculitis.
The subject is a chronic systemic steroid or recreational intranasal drug user.
The subject has had a cancerous or precancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
The subject has polyps or pathology (ie, septal deviation) other than turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction.
The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure.
The subject has a known or suspected allergy to polylactide polymer (PLA) or other absorbable materials.
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.
The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).
The subject is not a candidate for procedures conducted under local anesthesia and/or managed anesthesia care (MAC) or conscious sedation.
Female subjects of childbearing potential, known or suspected to be pregnant, or is lactating.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 166 participants (actual)

Study arms

Other
Latera Implant
Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.
Device: Nasal Implant

Interventions

DeviceNasal Implant
Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.

What researchers measure

Primary outcomes

Efficacy: Percent of Treatment Responders
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
Safety: Procedure- and/or Device-related Adverse Events
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

Secondary outcomes

Percent of Treatment Responders
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.
Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
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
Subject Satisfaction Questionnaire
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
Procedure and Device-related Adverse Events
Number of participants who experience procedure- or device-related adverse events.
Time frame: After 6 months and up to 12 months post procedure

Results

Posted Oct 30, 2019

Participant flow

Participant flow — Overall Study
Milestone	Latera Implant
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
Withdrew: Lost to follow-up	28
Withdrew: Withdrawal by subject	11
Withdrew: Lack of efficacy	10
Withdrew: Did not consent to long-term fu	14
Withdrew: Death	1

Outcome measures

PrimaryEfficacy: Percent of Treatment Responders

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
Reported as:: Count of participants · Participants

Efficacy: Percent of Treatment Responders
Participants	Latera Implant
Efficacy: Percent of Treatment Responders	136

Statistical analysis

Latera Implant · Proportion: 89.5 · 95% CI 83.5 to 93.9

PrimarySafety: Procedure- and/or Device-related Adverse Events

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
Reported as:: Count of participants · Participants

Safety: Procedure- and/or Device-related Adverse Events
Participants	Latera Implant
Safety: Procedure- and/or Device-related Adverse Events	31

SecondaryPercent of Treatment Responders

Time frame:: 1, 3, 12, 18, and 24 months post procedure.
Reported as:: Count of participants · Participants

Percent of Treatment Responders
Participants	Latera Implant
1-Month Follow-up	147
3-Month Follow-up	143
12-Month Follow-up	124
18-Month Follow-up	103
24-Month Follow-up	93

SecondaryChange in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)

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
Reported as:: Mean · score on a scale

Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)
score on a scale	Latera Implant
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

Latera Implant · t-test, 2 sided · p = <0.001 (P values are based on paired t-tests for change from baseline with p\<0.05 indicating significance.)

SecondarySubject Satisfaction Questionnaire

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
Reported as:: Count of participants · Participants

Subject Satisfaction Questionnaire
Participants	Latera Implant
Subject Satisfaction Questionnaire	115

SecondaryProcedure and Device-related Adverse Events

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

Time frame:: After 6 months and up to 12 months post procedure
Reported as:: Count of participants · Participants

Procedure and Device-related Adverse Events
Participants	Latera Implant
Procedure and Device-related Adverse Events	3

Adverse events

Collected over 24 months post procedure. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Latera Implant	1/166 (0.6%)	0/166 (0%)	24/166 (14.5%)

Most frequent other events

Most frequent other events
Event	Latera Implant
Implant migration/retrievalSurgical and medical procedures	15/166
Sinus infectionInfections and infestations	10/166

Baseline characteristics

All participants enrolled and treated with the Latera Implant.

Age, Continuous
Age, Continuous(years)	Latera Implant
Mean	50.5 ± 14.9

Sex: Female, Male
Sex: Female, Male(Participants)	Latera Implant
Female	82
Male	84

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Latera Implant
Race — American Indian or Alaska Native	1
Race — Asian	3
Race — Black or African American	3
Race — Hispanic or Latino	11
Race — White	143
Race — Other	4
Race — Not Specified	1

Region of Enrollment
Region of Enrollment(participants)	Latera Implant
United States	166

NOSE score (100-point scale)
NOSE score (100-point scale)(units on a scale)	Latera Implant
Mean	77.4 ± 13.4

Nose Severity Class
Nose Severity Class(Participants)	Latera Implant
Severe	90
Extreme	76

Nasal Obstruction Visual Analog Scale (VAS)
Nasal Obstruction Visual Analog Scale (VAS)(units on a scale)	Latera Implant
Mean	68.0 ± 18.0

Study locations

9 sites

Beverly Hills Aesthetic Surgical Institute
Beverly Hills, California 90210, United States
Alessi Institute For Facial Plastic Surgery
Beverly Hills, California 90212, United States
ENT Assoc. of South Florida
Boca Raton, Florida 33487, United States
The Center for Sinus, Allergy, & Sleep Wellness
Boynton Beach, Florida 33472, United States
ENT of Georgia
Atlanta, Georgia 30342, United States
Chicago Nasal & Sinus Center
Chicago, Illinois 60602, United States
Madison ENT & Facial Plastic Surgery
New York, New York 10016, United States
Collin County ENT
Frisco, Texas 75034, United States
Ogden Clinic
Ogden, Utah 84403, United States

References and documents

Publications

Sidle DM, Stolovitzky P, Ow RA, Silvers S, Matheny K, Bikhazi N, Wani M, Scurry WC, Most SP. Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse. Laryngoscope. 2020 May;130(5):1132-1137. doi: 10.1002/lary.28151. Epub 2019 Jun 28. PubMed 31254279 ↗
Stolovitzky P, Sidle DM, Ow RA, Nachlas NE, Most SP. A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant. Laryngoscope. 2018 Nov;128(11):2483-2489. doi: 10.1002/lary.27242. Epub 2018 May 14. PubMed 29756407 ↗
Sidle DM, Stolovitzky P, O'Malley EM, Ow RA, Nachlas NE, Silvers S. Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures. Facial Plast Surg. 2021 Oct;37(5):673-680. doi: 10.1055/s-0041-1726464. Epub 2021 Apr 14. PubMed 33853139 ↗

Study documents

Protocol and statistical analysis plan · Sep 7, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT02964312
Lead sponsor: Spirox, Inc.
Collaborators: New Arch Consulting
Responsible party: Sponsor
First posted: Nov 16, 2016
Start date: Nov 10, 2016
Primary completion: Mar 21, 2018
Completion: Aug 29, 2019
Results posted: Oct 30, 2019
Last update: Sep 3, 2020

Study contacts

Douglas Sidle, MD

principal investigator · Northwestern University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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