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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyester Implants | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyester Implants | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks after implantation |
| 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. | 12 weeks after implantation |
| Safety | Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis. | During 12-week original study and at long-term follow-up of 11 months or longer |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Terry L Donat, MD | Institute of Aesthetic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817-2207 | United States | ||
| Premier Image Cosmetic & Laser |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16549736 | Background | Hurbis CG. An adjustable, butterfly-design, titanium-expanded polytetrafluoroethylene implant for nasal valve dysfunction: a pilot study. Arch Facial Plast Surg. 2006 Mar-Apr;8(2):98-104. doi: 10.1001/archfaci.8.2.98. | |
| 14990910 | Background | Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. 2004 Feb;130(2):157-63. doi: 10.1016/j.otohns.2003.09.016. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Original Study |
| |||||||||||||
| Long-term Follow-up Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | 12 weeks after implantation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temporary pain implant site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Hodge, Project Manager | Medtronic Xomed, Inc. | (+1-904) 281-2774 | david.l.hodge@medtronic.com |
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| ID | Term |
|---|---|
| C563533 | Nasal Alar Collapse, Bilateral |
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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|
| Atlanta |
| Georgia |
| 30338-6408 |
| United States |
| DuPage Medical Group, Ltd | Downers Grove | Illinois | 60515 | United States |
| Ear, Nose, & Throat Physicians | Sterling Heights | Michigan | 48314 | United States |
| HealthPartners Specialty Clinic/Regions Hospital | Saint Paul | Minnesota | 55130 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
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.
|
|
|
| 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. | 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. | Posted | Number | participants | 12 weeks after implantation |
|
|
|
|
| Primary | Safety | Evaluate complications and adverse events. Events are presented descriptively with no statistical analysis. | All enrolled subjects' adverse events were collected. | Posted | Number | events | During 12-week original study and at long-term follow-up of 11 months or longer |
|
|
|
| 0 |
| 45 |
| 36 |
| 45 |
| Partial extrusion | Surgical and medical procedures | Non-systematic Assessment |
|
| Foreign body sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Upper respiratory infection/viral cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cosmetic contour deformity | Surgical and medical procedures | Non-systematic Assessment |
|
| Swelling/edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Minimal bleeding | Surgical and medical procedures | Non-systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| Title | Measurements |
|---|---|
|
| GAIS: Improved (After correct order ID) |
|
| GAIS: Much improved (After correct order ID) |
|
| GAIS: Very much improved (After correct order ID) |
|
| GAIS: Could not evaluate (After correct order ID) |
|
| GAIS: Worse (After incorrect order ID) |
|
| Title | Measurements |
|---|---|
|
| Upper respiratory infection/viral cold |
|
| Cosmetic contour deformity |
|
| Swelling/edema |
|
| Minimal bleeding |
|
| Cellulitis |
|
| Fever |
|
| Redness of skin |
|
| Tenderness |
|
| Vestibulitis |
|
| Sinus infection |
|
| Vomiting |
|
| Full extrusion |
|
| Infection |
|
| Bronchitis |
|
| Ecchymosis right cheek |
|
| Halitosis dysgusia |
|
| Herniated disc |
|
| Intranasal irritation/crust |
|
| Mild bruising perinasal |
|
| Numbness to tip of nose |
|
| Post inflammatory neuralgia |
|
| Pustule w/ implant exposure |
|
| Surface irritation sensation |
|
| Scarring |
|