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The goal of this study is to evaluate the efficacy of using the Vivaer low-temperature radio-frequency (LTRF) device to reshape ex-vivo human nasal or auricular cartilage for use in cosmetic and functional septorhinoplasty. The investigators hope to answer the following questions:
Participants will complete the NOSE questionnaire at their pre-operative visit. Participants undergoing cosmetic septhorhinoplasty will also be photographed in standard fashion for facial analysis.
During scheduled septorhinoplasty surgery, the Vivaer LTRF device will be used to reshape nasal and/or auricular cartilage ex-vivo prior to reimplantation at the discretion of the Principal Investigator in order to optimize functional and cosmetic outcome.
Participants will follow up at approximately 1 week and 1 month after surgery. At 1 month, the NOSE questionnaire will be readministered to all participants, and cosmetic patients will be photographed again.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-temperature radio-frequency reshaping intervention | Experimental | All enrolled subjects will receive the intervention outlined in the section titled "Study Design". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage | Device | The device settings will be set per the manufacturer's instructions: temperature = 60° C, power = 4 W, treatment time = 18 seconds, and cooldown = 12 seconds. For curved-to-straight (CTS) samples (natively curved cartilage to be remolded to be flat), the cartilage specimens will be placed on a blue towel on a flat surface with the transmission medium over top and treated. For straight-to-curved (STC) samples (natively flat cartilage to be remolded to be curved), cartilage specimens will be placed along the inner surface of various shallow, plastic, cylindrical objects with the transmission medium over top and treated. Various device settings may be tested for reshaping efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatments needed to reach desired shape | The primary outcome measure will be the efficacy of reshaping cartilage from straight to curved and from curved to straight for use in septorhinoplasty. The number of treatments needed to create the desired shapes and curvatures will be measured for each cartilage specimen. | Immediately pre and post intervention (intraoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in specimen curvature | The angle of curvature of each specimen will be measured as the angle of the intersection between two lines drawn along the distal edges of the specimen. The difference in angle of curvature before and after low-temperature radiofrequency treatment will be calculated. | Immediately pre and post intervention (intraoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Reimplantation of LTRF-shaped specimens | Binary documentation of whether or not LTRF-shaped specimens are ultimately reimplanted. | Immediately pre and post intervention (intraoperative) |
| Time spent using low-temperature radiofrequency device |
Inclusion Criteria:
• Patients 18 years and older undergoing functional septorhinoplasty or cosmetic septorhinoplasty, with or without auricular cartilage harvest
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Victor, MD | Contact | 4803499146 | mtvictor@iu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Methodist Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Change in specimen length | The apparent length of each specimen before and after treatment will be measured as a straight line between the distal points of the cartilage sample. . The differences in length before and after low-temperature radiofrequency treatment will be calculated. | Immediately pre and post intervention (intraoperative) |
| Nasal Obstruction Symptom Evaluation (NOSE) score | Nasal Obstruction Symptom Evaluation (NOSE) score, a validated patient-reported outcome measure of nasal airway obstruction, will be obtained at the first pre-operative visit and at the second post-operative visit (approximately 1 month after surgery). Nasal obstruction severity classification: mild (5-25) moderate (30-50) severe (55-75) extreme (80-100). | Baseline and one month |
| Physician satisfaction with cosmetic outcome | Preoperative and postoperative standard septorhinoplasty photographs will be compared and rated by the surgeon. In cosmetic rhinoplasty, it is standard practice to take full-face patient photographs before and after surgery to assess cosmetic outcomes (frontal, lateral, oblique, nasal base angles). Full face photographs are necessary to include all soft tissue and bony landmarks to assess nasal proportions relative to the face. They will be stored in the Vectra imaging suite software used for facial plastic surgery photography, which is currently in use clinically and is HIPPA-compliant. | Baseline and one month |
Time spent (minutes) using LTRF device will be recorded to quantify addition of operative time.
| Immediately pre and post intervention (intraoperative) |
| IU Health North Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| IU Health Saxony Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| IU Health University Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| IU Health West Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Riley Hospital for Children at IU Health | Recruiting | Indianapolis | Indiana | 46202 | United States |
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