A Multi-center, Randomized, Open label, Comparison, Pivotal Clinical Trial to Evaluate the Safety and Efficacy of Porcine Rib Cartilage for Rhinoplasty
- Conditions
- Not Applicable
- Registration Number
- KCT0002769
- Lead Sponsor
- Hans Biomed Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 74
1. Persons over the age of 19
2. 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.
3. 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.
4. Persons who want rhinoplasty for the restoration of the nose deformed due to cosmetic procedure
surgery, congenital/acquired deformity or aging.
5. Persons who showed normal blood coagulation, renal function and liver function during screening
6. 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.
1. Other than this investigational medical device, Persons who have history of injecting an autogenous fat, an autogenous dermal fat, and other foreign materials at the surgical site. Or persons who are scheduled to be fitted with another device.
2. Persons who have infection, contamination, or severe scar contraction at the surgical site.
3. Persons who have severe nose-related diseases such as rhinitis, sinusitis and nasal concha hypertrophy, etc.
4. Persons who have hepatic dysfunction or blood clotting disorders or shall be treated with anticoagulants (Heparin, Warfarin) or aspirin (low dose aspirin 100 mg, up to 300 mg / day) during this clinical period.
5. Persons who have medical history of hypertrophic scarring or keloids.
6. Persons who have malignant atopic dermatitis.
7. Persons who have medical history of anaphylactic or severe allergy symptoms, or showed hypersensitivity to pig-derived materials in the past.
8. Persons who showed hypersensitivity to lidocaine or amide-based topical anesthetics in the past.
9. When screening, Persons who have ongoing or uncontrolled infectious diseases or persons who have immune-related diseases that can interfere with wound healing, or persons who expected to be treated or will be treated with immunosuppressants or corticosteroids during the clinical trial period.
10. When screening, Persons who showed clinically serious disorders in ENT system, cardiovascular system, digestive system, respiratory system, endocrine system, central nervous system, circulatory system and musculoskeletal system and immune system, or persons who have mental diseases which may have effect on this clinical trial.
11. When screening, Women who are pregnant or breast-feeding, or women who are planning for pregnancy during the clinical trial, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
* Medically acceptable contraceptive methods: Condoms, oral contraception for at least 3 months, use of contraceptive for injection or insertion, intrauterine contraceptive device.
12. Persons who participated in other clinical trials within one month before screening.
13. Other than above, Persons who considered to be unsuitable for this clinical trial as judged by medical opinion and clinical opinion from the (principal) investigator.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Changes in the subject's ROE (Rhinoplasty outcome evaluation) scores at 4 weeks after the implantation of the investigational medical device, comparing before the implantation of the investigational medical device (Subject’s evaluation);Changes (Nasofrontal angle, Nasolabial angle, Nasal tip projection) 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);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)