Clinical trial to evaluate the efficacy and safety of equine cartilage for rhinoplasty

INTERVENTION: Medical Device : This trial is a singlei‐center, Randomized, Comparative and Pivotal Clinical Trial. Once subjects who met the selection / exclusion criteria signed a consent form voluntarily and are enrolled in this trial, the investigator will randomize the subject according to randomization code table.The ratio between the randomly assigned test group and comparative group shall be 1:1. MegaCartilage‐E as the investigational medical device and the silicone implant as comparative medical device will be implanted into the subject. The subject will visit the institution at 4, 24, and 48 weeks after surgery for the evaluation of the efficacy and safety of the investigational medical device. CONDITION: Factors influencing health status and contact with health servisces PRIMARY OUTCOME: Changes in the subject's ROE (Rhinoplasty outcome evaluation) score at 24 weeks after the implantation of investigational medical device comparing before the implantation of investigational medical device (Subject’s evaluation) SECONDARY OUTCOME: Changes (Nasofrontal angle, height of Nasion) in the surgical site at 4 weeks, 24 weeks, 48 weeks after the implantation of the investigational medical device comparing before implantation of the investigational medical device (Independent evaluator’s evaluation) Changes in the subject's ROE (Rhinoplasty outcome evaluation) scores at 4 and 48 weeks after the implantation of the investigational medical device, comparing before the implantation of the investigational medical device (Subject’s evaluation) Global Aesthetic Improvement Scale (GAIS) evaluation by the investigator at 4 weeks, 24 weeks and 48 weeks after the implantation of the investigational medical device (Investigator’s evaluation) INCLUSION CRITERIA: ‐Persons over the age of 19 ‐ After hearing explanation and fully understood the details of the clinical trial, Persons who have voluntarily decided to participate in the clinical trial, thereafter have signed the consent form by themselves or legal representatives. ‐Persons who heard full explanation about the procedures, effects and side effects of anesthesia, surgical procedures, and screening related to this trial and have signed the consent form provided by the relevant institution. ‐Persons who want rhinoplasty for the restoration of the nose deformed due to congenital/acquired deformity or aging. ‐Persons who showed normal blood coagulation, renal function and liver function during screening ‐Persons who did not undergo surgery on the corresponding site within 1 year before screening and recovered from the side effects of the treatment in the past.