KCT0007858已完成未知
The multi-center, randomized, subject/evaluator blind, active-controlled, non-inferiority pivotal clinical study to compare the efficacy and safety of Collabarrier® with Guardix-sol for the prevention of postoperative adhesion after operation for disc herniation or spinal stenosis
Dalim Tissen0 个研究点目标入组 68 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 68
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 o Limit（—）
- 性别
- All
入选标准
- •1) Male and female adults over the age of 19
- •2) Patients who has been diagnosed with disc herniation or spinal stenosis through a radiological (MRI or CT) proof on nerve root compression on one level of L3-L4 or L4-L5 or L5-S1.
- •3) Patients who is supposed to undergo partial laminectomy or percutaneous lumbar discectomy to be cured of the symptoms specified above in the 2).
- •4) Patients relevant to any of following cases:
- •A. Patients who took prior conservative cure for at least 4 weeks for 6 months before V1(patients who took any of such therapies and drugs as physical therapy, anti-inflammatory drug, muscle relaxant and etc.)
- •B. Patients who suffers any unbearable pain and is determined by the relevant researcher to need to undergo a surgery for slipped disk or lumbar spinal stenosis
- •C. Patients with neurological function considerably lost
- •5) Voluntary consent in document form is needed; and the volunteer must be able to comply with the clinical test procedures and schedule.
排除标准
- •1) Patients who shows alergic reaction or has previous stroke to main and other ingredients or components of the medical device for this clinical test
- •2) Patients with a medical history of brittle bone
- •3) Patients with a medical history of fracture in lumbar region or ligament injuries by external injury
- •4) Patients who needs to undergo a spine surgery (osteotomy allowable) in addition to partial laminectomy or percutaneous lumbar discectomy for cure of symptom
- •5) Patients with neurological function disorder on intestine/bladder
- •6) Patients with any of such symptoms as excessive exudation, bleeding, acute edema and infection on the part applied
- •7) Patients with Degenerative spinal disorder (other than disc herniation or spinal stenosis) or scoliosis (Cobb’s angle is 15° or bigger)
- •8) Patients with any of lymphatic disease, coagulation disoder and/or coagulant taken
- •9) Patients with uncontrolled diabetes that may affect the surgery or the progress after surgery based on the tester’s judgment
- •10) Patients with desmosis or autoimmune disease or who has ever taken malignant tumor treatment within 5 years before this surgery
- •11) Patients who has ever undergone a spine surgery on the part for this surgery
- •12) Patients who has ever taken extradural steroid treatment within 2 weeks before surgery or oral steroid drug within 10 days before surgery
- •13) Patients who has ever taken myelogram or lumbar puncture within 24 hours before screening
- •14) Patients with impaired immunity or clinically significant abnormalities in clinical laboratory tests at screening Patients with immunity deteriorated or who shows clinically significant abnormality in lab test items at the moment of screening
- •15) Patients who present clinically severe impairment in cardiovascular, digestive, respiratory, endocrine, or central nervous system, or have a mental illness that significantly affects the trial
- •16) Participated in other clinical trials within 30 days from the screening
- •17) A pregnant woman or lactating woman
- •18) Patients who cannot comply with any requirement of the document form consent for this clinical test from the signing date of signature on the consent till the final day of visit
- •19) Patients determined by the researcher to be non-conformable to this clinical trials.
研究者
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