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

Not Applicable

Completed

• Conditions: Nasal Obstruction
• Interventions: Device: Nasal Implant

• Registration Number: NCT02952313
• Lead Sponsor: Spirox, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-02
• Primary Completion: 2018-03
• Results First Submitted: 2019-03-07
• Results First Submitted QC: 2019-03-29
• Results First Posted: 2019-04-23
• Study Completion: 2019-08
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Latera Implant	Nasal Implant	All participants have unilateral or bilateral placement of LATERA Nasal Implants.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percent of Treatment Responders	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).
Subject Satisfaction Questionnaire	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.
Procedure and Device Related Adverse Events	After 6 months and up to 24 months post procedure	Number of participants who experience procedure or device-related adverse events.
Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).	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.

Trial Locations

Locations (12)

ENT New Orelans; 🇺🇸 Marrero, Louisiana, United States

ENT of Georgia; 🇺🇸 Atlanta, Georgia, United States

Beverly Hills Aesthetic Surgical Institute; 🇺🇸 Beverly Hills, California, United States

Collin County ENT; 🇺🇸 Frisco, Texas, United States

Chicago Nasal & Sinus Center; 🇺🇸 Chicago, Illinois, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Madison ENT & Facial Plastic Surgery; 🇺🇸 New York, New York, United States

Piedmont ENT; 🇺🇸 Winston-Salem, North Carolina, United States

ENT & Allergy Center of Austin; 🇺🇸 Austin, Texas, United States

The Center for Sinus, Allergy & Sleep Wellness; 🇺🇸 Boynton Beach, Florida, United States

ENT Assoc. of South Florida; 🇺🇸 Boca Raton, Florida, United States

Ogden Clinic; 🇺🇸 Ogden, Utah, United States