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

• ClinicalTrials.gov Identifier: NCT02952313
• Recruitment Status: Completed
• First Posted: November 2, 2016
• Results First Posted: April 23, 2019
• Last Update Posted: September 1, 2020
• Sponsor: Spirox, Inc.
• Information provided by (Responsible Party): Spirox, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Nasal Obstruction	Device: Nasal Implant	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 113 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: March 2018
• Actual Study Completion Date: August 2019

Arms and Interventions

Arm	Intervention/treatment
Latera Implant; All participants have unilateral or bilateral placement of LATERA Nasal Implants.	Device: Nasal Implant

Outcome Measures

Primary Outcome Measures :

1. The Primary Efficacy Endpoint is the Percent of Treatment Responders [ Time Frame: 6 months post procedure ]
   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).
2. Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events [ Time Frame: 6 months post procedure ]
   Number of participants with a device-related or procedure-related adverse event

Secondary Outcome Measures :

1. Percent of Treatment Responders [ Time Frame: 1, 3 12, 18, and 24 months post procedure. ]
   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).
2. Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS). [ Time Frame: 1, 3, 6, 12, 18, and 24 months post procedure ]
   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.
3. Subject Satisfaction Questionnaire [ Time Frame: 6 months ]
   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.
4. Procedure and Device Related Adverse Events [ Time Frame: After 6 months and up to 24 months post procedure ]
   Number of participants who experience procedure or device-related adverse events.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

Beverly Hills Aesthetic Surgical Institute

Beverly Hills, California, United States, 90210

United States, Florida

ENT Assoc. of South Florida

Boca Raton, Florida, United States, 33487

The Center for Sinus, Allergy & Sleep Wellness

Boynton Beach, Florida, United States, 33472

United States, Georgia

ENT of Georgia

Atlanta, Georgia, United States, 30342

United States, Illinois

Chicago Nasal & Sinus Center

Chicago, Illinois, United States, 60602

Northwestern University

Chicago, Illinois, United States, 606611

United States, Louisiana

ENT New Orelans

Marrero, Louisiana, United States, 70072

United States, New York

Madison ENT & Facial Plastic Surgery

New York, New York, United States, 10016

United States, North Carolina

Piedmont ENT

Winston-Salem, North Carolina, United States, 27103

United States, Texas

ENT & Allergy Center of Austin

Austin, Texas, United States, 78746

Collin County ENT

Frisco, Texas, United States, 75034

United States, Utah

Ogden Clinic

Ogden, Utah, United States, 84403

Sponsors and Collaborators

Spirox, Inc.

  Study Documents (Full-Text)

Documents provided by Spirox, Inc.:

Study Protocol  [PDF] September 7, 2017

Statistical Analysis Plan  [PDF] January 3, 2018

More Information

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Spirox, Inc.
• ClinicalTrials.gov Identifier: NCT02952313
• Other Study ID Numbers: SPI-CP-301
• First Posted: November 2, 2016
• Results First Posted: April 23, 2019
• Last Update Posted: September 1, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Nasal Obstruction; Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases