Clinical trial NCT02952313: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Lead sponsor: Spirox, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The Primary Efficacy Endpoint is the Percent of Treatment Responders
timeFrame: 6 months post procedure
measure: Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events
timeFrame: 6 months post procedure
Secondary outcomes:
measure: Percent of Treatment Responders
timeFrame: 1, 3 12, 18, and 24 months post procedure.
measure: Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).
timeFrame: 1, 3, 6, 12, 18, and 24 months post procedure
measure: Subject Satisfaction Questionnaire
timeFrame: 6 months
measure: Procedure and Device Related Adverse Events
timeFrame: After 6 months and up to 24 months post procedure
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Beverly Hills Aesthetic Surgical Institute
state: California
city: Boca Raton
country: United States
facility: ENT Assoc. of South Florida
state: Florida
city: Boynton Beach
country: United States
facility: The Center for Sinus, Allergy & Sleep Wellness
state: Florida
city: Atlanta
country: United States
facility: ENT of Georgia
state: Georgia
city: Chicago
country: United States
facility: Chicago Nasal & Sinus Center
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Marrero
country: United States
facility: ENT New Orelans
state: Louisiana
city: New York
country: United States
facility: Madison ENT & Facial Plastic Surgery
state: New York
city: Winston-Salem
country: United States
facility: Piedmont ENT
state: North Carolina
city: Austin
country: United States
facility: ENT & Allergy Center of Austin
state: Texas
city: Frisco
country: United States
facility: Collin County ENT
state: Texas
city: Ogden
country: United States
facility: Ogden Clinic
state: Utah
Study officials:
References:
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.
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.