Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-14

Study Completion Date

2027-06-30

Brief Summary

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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:

1. How many LTRF treatments are needed to achieve the desired shape in a given cartilage specimen
2. How does an LTRF treatment quantitatively affect both length and angulation of a cartilage specimen
3. How does physician satisfaction with cosmetic outcome compare to cases treated with existing septorhinoplasty techniques
4. How do changes in patient reported measures of nasal obstruction (NOSE score) pre- and post-surgery compare to cases treated with existing septorhinoplasty techniques
5. Does using LTRF during septorhinoplasty significantly increase total operative time
6. Are rates of adverse events when using LTRF different from cases treated with existing septorhinoplasty techniques

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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Detailed Description

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Conditions

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Nasal Valve Collapse Nose Enhancement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-temperature radio-frequency reshaping intervention

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Group Type EXPERIMENTAL

Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage

Intervention Type 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.

Interventions

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Low-temperature radio-frequency reshaping of autologous cartilage nasal and/or auricular cartilage

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

• Patients 18 years and older undergoing functional septorhinoplasty or cosmetic septorhinoplasty, with or without auricular cartilage harvest

Exclusion Criteria

* Patients who have had a prior septorhinoplasty
* Patients who have received prior head and neck radiation
* Patients with a septal perforation
* Patients who are medically ineligible to undergo septorhinoplasty.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Taha Shipchandler

Division Chief of Facial Plastic and Reconstructive Surgery in the Department of Otolaryngology-Head and Neck Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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