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CompletedNCT02952313Updated Sep 1, 2020Results posted

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

An interventional study of Nasal Implant in Nasal Obstruction, sponsored by Spirox, Inc.. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-01.

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

Phase
Not applicable
Study type
Interventional
Enrollment
113
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Nasal Obstruction

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
04

Study design

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

Study arms

  • Other
    Latera Implant

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

    Device: Nasal Implant

Interventions

  • DeviceNasal Implant
05

What researchers measure

Primary outcomes

  1. The Primary Efficacy Endpoint is the Percent of Treatment Responders

    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

  2. Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events

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

    Time frame: 6 months post procedure

Secondary outcomes

  1. Percent of Treatment Responders

    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.

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

    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

  3. 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

  4. 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 24 months post procedure

06

Results

Posted Apr 23, 2019

Participant flow

Primary Endpoint
Participant flow — Primary Endpoint
MilestoneLatera Implant
Started113
6 months106
Completed106
Not completed7
Withdrew: Lost to follow-up4
Withdrew: Withdrawal by subject1
Withdrew: Lack of efficacy1
Withdrew: Missed visit1
Long-term Follow-up
Participant flow — Long-term Follow-up
MilestoneLatera Implant
Started107
12-month93
18-month79
Completed75
Not completed32
Withdrew: Lost to follow-up12
Withdrew: Did not reconsent for long-term fu7
Withdrew: Lack of efficacy6
Withdrew: Withdrawal by subject5
Withdrew: Physician decision1
Withdrew: Death1

Outcome measures

PrimaryThe Primary Efficacy Endpoint is the Percent of Treatment Responders

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
Reported as:
Count of participants · Participants
The Primary Efficacy Endpoint is the Percent of Treatment Responders
ParticipantsLatera Implant
The Primary Efficacy Endpoint is the Percent of Treatment Responders101
PrimaryPrimary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events

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

Time frame:
6 months post procedure
Reported as:
Count of participants · Participants
Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events
ParticipantsLatera Implant
Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events10
SecondaryPercent of Treatment Responders

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.
Reported as:
Count of participants · Participants
Percent of Treatment Responders
ParticipantsLatera Implant
1-Month FU104
3-Month FU106
12-Month FU88
18-Month FU70
24-Month FU72
SecondaryChange in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).

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
Reported as:
Least squares mean · score on a scale
Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).
score on a scaleLatera Implant
1-Month FU-40.4 (-44.4 to -36.4)
3-Month FU-46.3 (-50.3 to -42.3)
6-Month FU-45.6 (-49.7 to -41.5)
12-Month FU-47.5 (-51.9 to -43.1)
18-Month FU-48.7 (-53.6 to -43.8)
24-Month FU-51.0 (-55.9 to -46.2)
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
ParticipantsLatera Implant
Subject Satisfaction Questionnaire89
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 24 months post procedure
Reported as:
Count of participants · Participants
Procedure and Device Related Adverse Events
ParticipantsLatera Implant
Procedure and Device Related Adverse Events1

Adverse events

Collected over Adverse events for the primary safety endpoint are reported for the 6-month period after the study procedure.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Latera Implant1/113 (0.9%)2/113 (1.8%)19/113 (16.8%)
Most frequent serious events
Most frequent serious events
EventLatera Implant
Gastrointestinal bleedGastrointestinal disorders1/113
Heart valve diseaseCardiac disorders1/113
Most frequent other events
Most frequent other events
EventLatera Implant
SinusitisInfections and infestations13/113
Implant retrieval/extrusionSurgical and medical procedures7/113

Baseline characteristics

Age, Continuous
Age, Continuous(years)Latera Implant
Mean45.3 ± 13.7
Sex: Female, Male
Sex: Female, Male(Participants)Latera Implant
Female49
Male64
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Latera Implant
Ethnicity — Non-Hispanic or Latino102
Ethnicity — Hispanic or Latino10
Ethnicity — Unspecified1
Region of Enrollment
Region of Enrollment(Participants)Latera Implant
United States113
NOSE Score (100-point scale)
NOSE Score (100-point scale)(units on a scale)Latera Implant
Mean78.5 ± 13.8
NOSE Severity Classification
NOSE Severity Classification(Participants)Latera Implant
Severe (NOSE Scores of 55-75)56
Extreme (Nose Scores of 80-10057
07

Study locations

12 sites
  • Beverly Hills Aesthetic Surgical Institute
    Beverly Hills, California 90210, 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
  • Northwestern University
    Chicago, Illinois 606611, United States
  • ENT New Orelans
    Marrero, Louisiana 70072, United States
  • Madison ENT & Facial Plastic Surgery
    New York, New York 10016, United States
  • Piedmont ENT
    Winston-Salem, North Carolina 27103, United States
  • ENT & Allergy Center of Austin
    Austin, Texas 78746, United States
  • Collin County ENT
    Frisco, Texas 75034, United States
  • Ogden Clinic
    Ogden, Utah 84403, United States
08

References and documents

Publications

  • 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

  • Study protocol · Sep 7, 2017
  • Statistical analysis plan · Jan 3, 2018

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

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT02952313
Lead sponsor
Spirox, Inc.
Responsible party
Sponsor
First posted
Nov 2, 2016
Start date
Sep 2016
Primary completion
Mar 2018
Completion
Aug 2019
Results posted
Apr 23, 2019
Last update
Sep 1, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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