Clinical trial NCT02964312: LATERA-OFFICE Study
Official title: Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OFFICE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Keywords: nasal valve collapse
absorbable nasal implant
Lead sponsor: Spirox, Inc.
Sponsor class: INDUSTRY
Collaborators: name: New Arch Consulting
First posted: 2016-11-16
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm intervention with pre/post comparison for treatment response.
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Efficacy: Percent of Treatment Responders
timeFrame: 6 months
measure: Safety: Procedure- and/or Device-related Adverse Events
timeFrame: 6 months
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 a 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 12 months post procedure
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Beverly Hills Aesthetic Surgical Institute
state: California
city: Beverly Hills
country: United States
facility: Alessi Institute For Facial Plastic Surgery
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: New York
country: United States
facility: Madison ENT & Facial Plastic Surgery
state: New York
city: Frisco
country: United States
facility: Collin County ENT
state: Texas
city: Ogden
country: United States
facility: Ogden Clinic
state: Utah
Study officials:
affiliation: Northwestern University
name: Douglas Sidle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.