LATERA-OFFICE Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Nasal Obstruction

Intervention / Treatment
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* Device: Nasal Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has Nasal Obstruction Symptom Evaluation (NOSE) score ≥55. The subject has dynamic lateral nasal wall insufficiency as confirmed by positive modified Cottle maneuver. The subject is ≥18 years of age. The subject is willing and able to provide informed consent and comply with the study protocol. 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. The subject has appropriate nasal and facial anatomy to receive the Latera Implant. The subject agrees to follow-up examinations through 12 months post operatively. 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: The subject is having a concurrent functional endoscopic sinus surgery (FESS) or sinuplasty. The subject has had rhinoplasty within the past 12 months. The subject is planning to have other concurrent rhinoplasty procedure. The subject is planning to have other rhinoplasty procedures or will use external dilators within 12 months after the index procedure. The subject has had septoplasty and/or inferior turbinate reduction within the past 6 months. The subject has, in the view of the clinician, inappropriate fixation on their nasal airway. 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. The subject has a permanent Implant or dilator in the nasal area. The subject has concomitant inflammatory or infectious skin conditions or unhealed wounds in the treatment area. The subject currently has active nasal vestibulitis. The subject has a history of nasal vasculitis. The subject is a chronic systemic steroid or recreational intranasal drug user. The subject has had a cancerous or precancerous lesion and/or has had radiation exposure in the treatment area or chemotherapy. The subject has polyps or pathology (ie, septal deviation) other than turbinate hypertrophy and/or lateral wall insufficiency that would contribute to airway obstruction. The subject has a history of a significant bleeding disorder(s) that would prevent healing of the treatment area post procedure. The subject has a known or suspected allergy to polylactide polymer (PLA) or other absorbable materials. 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. The subject is currently using nasal oxygen or continuous positive airway pressure (CPAP). The subject is not a candidate for procedures conducted under local anesthesia and/or managed anesthesia care (MAC) or conscious sedation. Female subjects of childbearing potential, known or suspected to be pregnant, or is lactating.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm intervention with pre/post comparison for treatment response.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal valve collapse, absorbable nasal implant