Back to resultsSpirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
Primary Purpose
Nasal Obstruction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal Implant
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Obstruction
Eligibility Criteria
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 Maneuver22.
- 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 nasal Implant procedure alone or with septoplasty and/or a turbinate reduction procedure in an operating room setting.
- The subject has appropriate nasal and facial anatomy to receive Latera Implant.
- The subject agrees to follow-up examinations through twelve (12) months post operatively.
- 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:
- The subject is having a concurrent Functional Endoscopic Sinus Surgery (FESS) or sinuplasty.
- The subject has had rhinoplasty within the past twelve (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 twelve (12) months after the index procedure.
- The subject has had septoplasty and/or inferior turbinate reduction within the past six (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 non-surgical treatment of their nasal valve, other than the index procedure, within twelve (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 intra-nasal drug user.
- The subject has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
- 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.
- 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 poly lactic acid (PLA) or other absorbable materials.
- 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.
- The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).
- The subject is not a candidate for procedures conducted under general anesthesia, managed anesthesia care (MAC) or conscious sedation.
- If female, subject is known or suspected to be pregnant or is lactating.
Sites / Locations
- Beverly Hills Aesthetic Surgical Institute
- ENT Assoc. of South Florida
- The Center for Sinus, Allergy & Sleep Wellness
- ENT of Georgia
- Chicago Nasal & Sinus Center
- Northwestern University
- ENT New Orelans
- Madison ENT & Facial Plastic Surgery
- Piedmont ENT
- ENT & Allergy Center of Austin
- Collin County ENT
- Ogden Clinic
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Latera Implant
Arm Description
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Outcomes
Primary Outcome Measures
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).
Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events
Number of participants with a device-related or procedure-related adverse event
Secondary Outcome Measures
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).
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.
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.
Procedure and Device Related Adverse Events
Number of participants who experience procedure or device-related adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02952313
Brief Title
Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
Official Title
Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spirox, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Latera Implant
Arm Type
Other
Arm Description
All participants have unilateral or bilateral placement of LATERA Nasal Implants.
Intervention Type
Device
Intervention Name(s)
Nasal Implant
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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.
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Maneuver22.
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 nasal Implant procedure alone or with septoplasty and/or a turbinate reduction procedure in an operating room setting.
The subject has appropriate nasal and facial anatomy to receive Latera Implant.
The subject agrees to follow-up examinations through twelve (12) months post operatively.
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:
The subject is having a concurrent Functional Endoscopic Sinus Surgery (FESS) or sinuplasty.
The subject has had rhinoplasty within the past twelve (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 twelve (12) months after the index procedure.
The subject has had septoplasty and/or inferior turbinate reduction within the past six (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 non-surgical treatment of their nasal valve, other than the index procedure, within twelve (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 intra-nasal drug user.
The subject has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy.
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.
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 poly lactic acid (PLA) or other absorbable materials.
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.
The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP).
The subject is not a candidate for procedures conducted under general anesthesia, managed anesthesia care (MAC) or conscious sedation.
If female, subject is known or suspected to be pregnant or is lactating.
Facility Information:
Facility Name
Beverly Hills Aesthetic Surgical Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
ENT Assoc. of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
The Center for Sinus, Allergy & Sleep Wellness
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
ENT of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Chicago Nasal & Sinus Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606611
Country
United States
Facility Name
ENT New Orelans
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Madison ENT & Facial Plastic Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Piedmont ENT
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
ENT & Allergy Center of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Collin County ENT
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Ogden Clinic
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29756407
Citation
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.
Results Reference
result
PubMed Identifier
33853139
Citation
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.
Results Reference
derived
Learn more about this trial
Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
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