KCT0003847已完成未知
Clinical trial to evaluate the efficacy and safety of equine cartilage for rhinoplasty : multicenter, double-blind, non-inferiority, randomized confirmatory study
&C BIO0 个研究点目标入组 56 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •-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.
- •-Persons who have infection, contamination, or severe scar contraction at the surgical site.
- •-Persons who have severe nose-related diseases such as rhinitis, sinusitis and nasal concha hypertrophy, etc.
- •-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.
- •-Persons who have medical history of hypertrophic scarring or keloids.
- •-Persons who have malignant atopic dermatitis.
- •-Persons who have medical history of anaphylactic or severe allergy symptoms, or showed hypersensitivity to pig-derived materials in the past.
- •-Persons who showed hypersensitivity to lidocaine or amide-based topical anesthetics in the past.
- •-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.
- •-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.
- •-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.
- •-Persons who participated in other clinical trials within one month before screening.
- •-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.
研究者
相似试验
尚未招募
不适用
Clinical trial to evaluate the efficacy and safety of massage using a CMP-100 medical device in patients with shoulder-back myofascial pain syndromKCT0003971Wonkwang University, Gwangju Medical Center40
进行中（未招募）
不适用
Clinical trial to evaluate the efficacy and safety of MegaCarti® in Knee Cartilage DefectsDiseases of the musculoskeletal system and connective tissueKCT0004936&C BIO90
已完成
Unknown
Clinical trial to evaluate the efficacy and safety of nDM-14R intended for two-stage operation cases.Postoperative AdhesionJPRN-jRCT1092220091Kawasumi. laboratory .inc130
已完成
不适用
Clinical trial to evaluate the efficacy and safety of [11C]K-2 in healthy volunteershealthy volunteerJPRN-UMIN000020975Yokohama city university, school of medicine8
进行中（未招募）
不适用
Clinical trial with Transidose (=Lactulose) for oral intake regarding efficacy and safety in patients suffering from constipation.ConstipationMedDRA version: 18.1Level: PTClassification code 10010774Term: ConstipationSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2013-002900-15-DESalsarulo Pharma