LATERA-OFFICE Study

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

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.

Study Overview

• Status: Completed
• Conditions: Nasal Obstruction
• Intervention / Treatment: Device: Nasal Implant

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Latera Implant; Unilateral or bilateral placement of the Latera nasal implant for support of the lateral nasal wall cartilage.	Device: Nasal Implant; Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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).	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.	1, 3, 6, 12, 18, and 24 months post procedure
Procedure and Device-related Adverse Events	Number of participants who experience procedure- or device-related adverse events.	After 6 months and up to 12 months post procedure

Collaborators and Investigators

• Sponsor: Spirox, Inc.
• Collaborators: New Arch Consulting
• Investigators: Principal Investigator: Douglas Sidle, MD, Northwestern University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2016
• Primary Completion (Actual): March 21, 2018
• Study Completion (Actual): August 29, 2019

Study Registration Dates

• First Submitted: November 11, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: nasal valve collapse; absorbable nasal implant
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: SPI-CP-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No