Status:
COMPLETED
Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse
Lead Sponsor:
Spirox, Inc.
Conditions:
Nasal Valve Collapse
Eligibility:
All Genders
18+ years
Phase:
NA
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 su...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02188589
Start Date
April 1 2014
End Date
June 1 2017
Last Update
March 26 2019
Active Locations (1)
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1
Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde am Klinikum der LMU
Munich, Germany, 81377