Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction

NANot yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

June 1, 2027

Study Completion Date

June 30, 2027

Conditions
Nasal Valve CollapseNose Enhancement
Interventions
DEVICE

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.

Trial Locations (6)

46202

IU Health Methodist Hospital, Indianapolis

IU Health North Hospital, Indianapolis

IU Health Saxony Hospital, Indianapolis

IU Health University Hospital, Indianapolis

IU Health West Hospital, Indianapolis

Riley Hospital for Children at IU Health, Indianapolis

All Listed Sponsors
lead

Indiana University

OTHER

NCT07032675 - Cartilage Remodeling Using Low-Temperature Radiofrequency for Nasal Airway Reconstruction | Biotech Hunter | Biotech Hunter