NCT02940210Unknown3 期
A Randomized, Single-blind, Multi-center, Phase III Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy
CGBio Inc.1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2016年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Adhesion incidence rate following 8 weeks
研究概览
简要总结
A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy and safety of adhesion barrier Mediclore versus no treatment in patients with total thyroidectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Male or female at least 20 years of age
- •Patients without clinically significant lab
- •Patients scheduled for thyroidectomy
排除标准
- •Another clinical trials within 1 month
- •History of previous surgery on same position
- •Anticoagulant, general steroids within a week from surgery
- •Immunosuppression or autoimmune disease
- •General or local infection
- •Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
- •Incompatible medications
- •History of drug or alcohol abuse, mental disorder
- •Pregnant or lactating women and fertile women who is not using proper contraceptive method
- •History of esophagus diseases
- •Keloid symptoms
结局指标
主要结局
Adhesion incidence rate following 8 weeks
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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