Nasal Alar Collapse, Bilateral Clinical Trial
Official title:
Open Label, Baseline Controlled Study to Evaluate the Use of Polyethylene Terephthalate (PET) Implants for the Treatment of External Nasal Valve Collapse and Cosmetic Contour Deformity
The purpose of this study is to research a polyester polyethylene terephthalate (PET) implant for the treatment of external nasal valve collapse (NVC). NVC is a condition which causes narrowness and weakness in the nostril which results in nasal obstruction. Implants will be placed in the affected nostril(s). The implants are intended to restore the shape and stabilize the nasal wall to prevent nasal valve collapse and improve the symptoms associated with nasal obstruction.
The effects of PET implants on external NVC and cosmetic contour deformity will be evaluated
in an open-label, prospective study. Subjects for this clinical study will be recruited and
screened from clinic office visits and patient records at each principal investigator's site
as well as through an investigational review board (IRB)-approved general advertisement.
Those patients that continue to qualify after either screening process will be seen and
evaluated by one of the clinical investigators prior to enrollment in the study. Subjects
must meet criteria for the diagnosis of external nasal valve collapse as a stand alone
abnormality (i.e., symptoms of obstruction cannot be caused primarily by other factors).
Other contributing factors to the nasal obstruction must be ruled out and/or treated,
without relief before enrollment in this study. No other surgeries or procedures will be
allowed during the study that could influence the evaluation of implants on the treatment of
nasal valve collapse and cosmetic contour deformity. All subjects will be required to sign
an IRB approved informed consent prior to entry into the study.
After meeting inclusion/exclusion criteria and completing the pre-implant evaluations,
subjects will be scheduled for treatment with the polyethylene terephthalate implants. The
implant procedure will be performed by facial plastic physicians. All investigative sites
will be required to undergo training to standardize the methodology of implant technique and
administration of evaluation techniques (questionnaires, scales, photographic assessments,
etc.). Target sample size for the study will be 72 subjects.
Follow up evaluations for all outcome measures will occur at 1, 6, and 12 weeks after
implantation. Long-term follow-up for adverse events will be conducted at 11 months or later
after implantation.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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