KCT0005799尚未招募未知
A randomized, multi-center, subject/evaluator blind, non-inferiority, active-controlled design clinical study to evaluate the adhesion prevention and safety of HYCOGUARDgel® versus Guardix-SP ® in patients after operation for disc herniation or spinal stenosis
MEDIJ0 个研究点目标入组 96 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1) Men and women between the ages of 20 and 80
- •2) Persons diagnosed with disc herniation or lumbar stenosis through radiographic evidence (MRI or CT) for nerve root compression at the 4th, 5th lumbar or 5th lumbar spine
- •3) Among patients with the above diagnosis, those who are planning to perform spinal surgery such as nerve decompression or discectomy for the treatment of the above symptoms for the first time
- •4) Those who require spinal surgery because they do not have the therapeutic effect of related pain or paralysis through non-surgical treatments include disc herniation or lumbar stenosis
- •5) Those who understand and follow the instructions and who can participate during whole period throughout the clinical trial
- •6) Those who voluntarily decide to participate in this clinical trial and agree by writing on consent for clinical subjects.
排除标准
- •1) Those who are sensitive to hyaluronic acid, collagen, sodium carboxymethylcellulose
- •2) Patients with degenerative spinal cord disease (myelopathy) or scoliosis
- •3) Patients with lymphatic or blood clotting disorders, or who are administering blood coagulants
- •4) Those with uncontrolled diabetes that may affect surgery or postoperative progress at the judgment of the examiner
- •5) Those who received dural steroid treatment within 2 weeks from baseline or oral steroid within 10 days
- •6) Those who have collagen-vascular disease or autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus) or who have received treatment for malignant tumors within 5 years
- •7) Those who have received a myelogram or lumbar puncture within 24 hours from the baseline
- •8) Those with reduced immunity or who have clinically significant abnormalities in hematological, hematological, and urine tests, which are laboratory tests performed at the time of screening
- •9) Those who have clinically serious disorders in the cardiovascular system, digestive system, respiratory system, endocrine system, and central nervous system, or who have had or currently have mental disorders that significantly affect this clinical trial (e.g., cardiopulmonary disease, infectious disease , Coagulation and bleeding disorders, myocardial infarction, congestive heart failure, kidney failure, mental illness, epilepsy, schizophrenia, lack of cognitive ability, etc.).
- •10) Those who participated in clinical trials of other drugs or medical devices within one month prior to enrollment in this clinical trial
- •11) Those who do not agree to use a medically acceptable method of contraception* among female subjects who may be pregnant during the clinical trial period
- •* Medically acceptable method of contraception: condom, oral contraception lasting for at least 3 months, week In the case of using contraceptives for use or insertion, installation of an intrauterine contraceptive device, etc.
- •12) Pregnant or nursing women
- •13) In addition to the above criteria, those who has clinically significant findings that are considered inappropriate for this test by the person in charge of the study or in person in charge
研究者
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