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

Not Applicable

Completed

• Conditions: Nasal Valve Collapse
• Interventions: Device: INEX nasal implant

• Registration Number: NCT02188589
• Lead Sponsor: Spirox, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-11
• Primary Completion: 2015-12
• Results First Submitted: 2016-06-17
• Results First Submitted QC: 2016-08-16
• Results First Posted: 2016-10-10
• Study Completion: 2017-06
• Status Verified: 2018-11
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nasal implant group	INEX nasal implant	Bilateral or unilateral INEX nasal implants

Primary Outcome Measures

Name	Time	Method
Implant-related Adverse Events	6 months	Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)

Secondary Outcome Measures

Name	Time	Method
Breathing Capacity (NOSE Scores)	At baseline and at 6, 12, and 24 months post implant	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).
NOSE Responder Rate	At 6, 12, and 24 months post implant	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.

Trial Locations

Locations (1)

Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU; 🇩🇪 Munich, Germany