Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse

Study Overview
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Brief Summary
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To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.

Detailed Description
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This study is a multicenter, nonrandomized, prospective exploratory study of the INEX Nasal Implant. The purpose of this study is to evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.

Official Title
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Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse

Conditions
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Nasal Valve Collapse

Intervention / Treatment
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* Device: INEX nasal implant


Participation Criteria
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Eligibility Criteria
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Eligible participants are: Adult patients seeking treatment for nasal obstruction on one or both sides of the nose who are willing to undergo an office-based or intraoperative nasal implant procedure in lieu of alternative treatments (ie, surgical repair or use of an external dilator). Nasal valve collapse (NVC) must be a primary or significant contributor to the subject's nasal obstruction based on clinical presentation, physical examination and nasal endoscopy. Baseline Nasal Obstruction Symptom Evaluation (NOSE) score must be ≥55. Participants are excluded for the following: Surgical or non-surgical treatment of the nasal valve or rhinoplasty within 12 months before enrollment. Septoplasty, inferior turbinate reduction, or other surgical nasal procedures within 6 months before enrollment. Recurrent nasal infections. Use of intranasal steroids within 2 weeks preimplant and 2 weeks post implantation. Presence of a permanent implant, dilator, or uses an external device in the nasal area. Cancerous or precancerous lesions and/or radiation exposure in the treatment area or chemotherapy within 24 months of the study. Significant bleeding disorders. Significant systemic diseases. Currently using nasal oxygen or continuous positive airway pressure (CPAP).

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal implant group<br>Bilateral or unilateral INEX nasal implants | Device: INEX nasal implant<br>* Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant-related Adverse Events | Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing Capacity (NOSE Scores) | Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100). | At baseline and at 6, 12, and 24 months post implant | 
| NOSE Responder Rate | Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score. | At 6, 12, and 24 months post implant |