Study of Polyester Implants for the Treatment of External Nasal Valve Collapse (NVC)
Nasal Alar Collapse, Bilateral
Device: Polyester Implants
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Functional Improvement [ Time Frame: 12 weeks after implantation ] [ Designated as safety issue: No ]Functional improvement was defined as a subject who achieves both 1) an improvement in the physical condition of the collapsed nasal valve as evidenced by an increase of >= 10% in the change in volume during inspiration as measured by Vectra 3D photography from baseline to 12 weeks post-procedure; and 2) a reduction of at least 30% in the symptoms of nasal obstruction as measured by the Nasal Obstruction Symptom Evaluation Scale (NOSE) scale (5 questions with 0-4 scale from "Not a problem" to "Severe problem," possible score 0-100 via raw score × 5) from baseline to 12 weeks post-procedure.
- Cosmetic Improvement [ Time Frame: 12 weeks after implantation ] [ Designated as safety issue: No ]An independent clinician will review Vectra 3D photographs of each subject at baseline and at 12 weeks post-procedure to assess physical appearance of the external nasal wall. The clinician will be asked to determine which photographs are pre-treatment and which are post-treatment in the correct order. The clinician will then rate the photograph chosen as post-treatment using the Global Aesthetic Improvement Scale (GAIS; relative scale from "Worse" to "Very much improved"). If the post-treatment photograph was not correctly identified, that procedure will receive a "worse" on the rating scale.
- Safety [ Time Frame: During 12-week original study and at long-term follow-up of 11 months or longer ] [ Designated as safety issue: Yes ]Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.
|Study Start Date:||April 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Experimental: Polyester Implants
There is one arm for this study. All subjects in this study will receive the investigational nasal implants. See the detailed description for procedure information.
Device: Polyester Implants
Three polyester (PET) implants will be implanted in each side of the nose affected by external NVC. See the detailed description for information about the implant procedure.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729781
|United States, California|
|UC Davis Medical Center|
|Sacramento, California, United States, 95817-2207|
|United States, Georgia|
|Premier Image Cosmetic & Laser|
|Atlanta, Georgia, United States, 30338-6408|
|United States, Illinois|
|DuPage Medical Group, Ltd|
|Downers Grove, Illinois, United States, 60515|
|United States, Michigan|
|Ear, Nose, & Throat Physicians|
|Sterling Heights, Michigan, United States, 48314|
|United States, Minnesota|
|HealthPartners Specialty Clinic/Regions Hospital|
|St. Paul, Minnesota, United States, 55130|
|Principal Investigator:||Terry L Donat, MD||Institute of Aesthetic Surgery|