To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)
Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU
Munich, Germany
Implant-related Adverse Events
Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)
Time frame: 6 months
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).
Time frame: 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.
Time frame: At 6, 12, and 24 months post implant
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