Nasal Alar Collapse, Bilateral
Conditions
Keywords
nasal obstruction, airway resistance, soft tissue collapse, cosmetic contour deformity
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPolyester 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.
Sponsors
Medtronic
Medtronic Xomed, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is willing and able to sign an informed consent form * Is 18 years of age or older * Has positive response to any of the following based on patient history or office exam: * Use of Breath Rite Strips * Q-Tip test * Use of Nasal stents * Continuous manual distraction * Has inspiratory lateral nasal wall collapse or static medially obstructing lateral nasal wall position identified on physical exam * Has nasal valve that is narrow (either static or dynamic) based on a visual examination. * Has nasal septum that is considered stable and adequate to support the treatment of each nasal valve independently. * Is motivated and willing to comply with study and its follow-up requirements, including surgical intervention using the Pillar implant system for the treatment of nasal valve collapse * Speaks English * Has unilateral or bilateral nasal valve collapse
Exclusion criteria
* Has ability to achieve active nostril dilation and relieve obstruction using physiologic nasal alar and sidewall muscle actions * Has chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction. * Has active nasal infection * Has skin inflammation in the nasal area * Is a habitual chronic sniffer * Has septal deviation, turbinate hypertrophy, polyps, or ptotic nose tip believed to be causing obstruction * Has had previous rhinoplasty of external nasal frame * Requires another surgery other than implants to correct an obstruction * Has nasal anatomy that is inadequate to accommodate three 18 mm implants * Is participating in a clinical study for another treatment for nasal valve collapse * Is pregnant or desires to become pregnant during the duration of the study * Has a history of drug abuse or alcoholism in the year before enrollment * Has had previous surgery for external nasal valve collapse * Has an American Society of Anesthesiologists (ASA) rating of III or IV * Has any other condition believed to interfere with nasal assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Improvement | 12 weeks after implantation | 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 | 12 weeks after implantation | 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 | During 12-week original study and at long-term follow-up of 11 months or longer | Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polyester Implants There was one arm for this study. All subjects in this study received the investigational polyethylene terephthalate (PET) implants after enrollment in the original study. Subjects who could be reached and consented were enrolled in the long-term follow-up study, which was initiated to collect adverse events. See the detailed description for procedure information. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Polyester Implants |
|---|---|
| Age Continuous All subjects | 45.0 years STANDARD_DEVIATION 12.2 |
| Race/Ethnicity, Customized Hispanic | 2 participants |
| Race/Ethnicity, Customized White | 43 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 36 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Cosmetic Improvement
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.
Time frame: 12 weeks after implantation
Population: An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Polyester Implants | Cosmetic Improvement | Order of photos: Could not evaluate | 11 participants |
| Polyester Implants | Cosmetic Improvement | GAIS: Worse (After correct order ID) | 4 participants |
| Polyester Implants | Cosmetic Improvement | GAIS: No change (After correct order ID) | 15 participants |
| Polyester Implants | Cosmetic Improvement | GAIS: Improved (After correct order ID) | 7 participants |
| Polyester Implants | Cosmetic Improvement | GAIS: Much improved (After correct order ID) | 0 participants |
| Polyester Implants | Cosmetic Improvement | GAIS: Very much improved (After correct order ID) | 0 participants |
| Polyester Implants | Cosmetic Improvement | GAIS: Could not evaluate (After correct order ID) | 0 participants |
| Polyester Implants | Cosmetic Improvement | GAIS: Worse (After incorrect order ID) | 8 participants |
p-value: >0.99One-sided, binomial exact test
Primary
Functional Improvement
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.
Time frame: 12 weeks after implantation
Population: An implanted subject with missing data at 12 weeks of follow-up had the 6-week data carried forward to 12 weeks for analysis. If the 6-week data was unavailable, the subject's treatment was considered a failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Polyester Implants | Functional Improvement | ≥ 30% reduction in NOSE score | 40 participants |
| Polyester Implants | Functional Improvement | ≥ 10% increase in volume deflection (Vectra 3D) | 30 participants |
| Polyester Implants | Functional Improvement | ≥ 30% NOSE reduction and ≥ 10% Vectra 3D increase | 26 participants |
Comparison: This study had two independent primary endpoints (cosmetic and functional improvement). Therefore, the assumed type I error rate for each was 2.5% in order to maintain an overall 5% type I error rate. For each endpoint, the percent of subjects with improvement of the total number implanted was to be compared to a rate of 50% using a one-sided, binomial exact test. If the p-value was \< 0.025, the objective would have been met.p-value: 0.19One-sided, binomial exact test
Primary
Safety
Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis.
Time frame: During 12-week original study and at long-term follow-up of 11 months or longer
Population: All enrolled subjects' adverse events were collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Polyester Implants | Safety | Ecchymosis right cheek | 1 events |
| Polyester Implants | Safety | Halitosis dysgusia | 1 events |
| Polyester Implants | Safety | Herniated disc | 1 events |
| Polyester Implants | Safety | Scarring | 1 events |
| Polyester Implants | Safety | Pustule w/ implant exposure | 1 events |
| Polyester Implants | Safety | Temporary pain implant site | 39 events |
| Polyester Implants | Safety | Partial extrusion | 17 events |
| Polyester Implants | Safety | Foreign body sensation | 11 events |
| Polyester Implants | Safety | Upper respiratory infection/viral cold | 8 events |
| Polyester Implants | Safety | Cosmetic contour deformity | 7 events |
| Polyester Implants | Safety | Swelling/edema | 7 events |
| Polyester Implants | Safety | Minimal bleeding | 4 events |
| Polyester Implants | Safety | Cellulitis | 3 events |
| Polyester Implants | Safety | Fever | 2 events |
| Polyester Implants | Safety | Redness of skin | 2 events |
| Polyester Implants | Safety | Tenderness | 2 events |
| Polyester Implants | Safety | Vestibulitis | 2 events |
| Polyester Implants | Safety | Sinus infection | 2 events |
| Polyester Implants | Safety | Vomiting | 2 events |
| Polyester Implants | Safety | Full extrusion | 1 events |
| Polyester Implants | Safety | Infection | 1 events |
| Polyester Implants | Safety | Bronchitis | 1 events |
| Polyester Implants | Safety | Intranasal irritation/crust | 1 events |
| Polyester Implants | Safety | Mild bruising perinasal | 1 events |
| Polyester Implants | Safety | Numbness to tip of nose | 1 events |
| Polyester Implants | Safety | Post inflammatory neuralgia | 1 events |
| Polyester Implants | Safety | Surface irritation sensation | 1 events |