KCT0002946已完成未知
The Prospective, multicenter, double-blinded(Subject-independent evaluator), randomized, and pivotal clinical trial to compare the efficacy and safety of Collabarrier® with Guardix-SOL for the prevention of postoperative adhesion in Intrauterine surgery.
Dalim Tissen0 个研究点目标入组 188 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
- 188
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
- Female
入选标准
- •1. Female at least 19 years old
- •2. Patients scheduled for intrauterine surgery because of the following gynecological diseases
- •- Submucosal myoma
- •- Endometrial polyp
- •- Uterine septa
- •- Endometrial hyperplasia
- •- Intrauterine adhesion
- •- Abnormal uterine bleeding
- •3. Patients who are willing to voluntarily participate in the trial and are willing to follow the protocol
排除标准
- •If any of the following criteria are met, a target subject can not be enrolled.
- •? Pregnant, lactating women, and women having a pregnancy plan during the clinical trial
- •? Patients who intend to use an intrauterine device for contraception during the clinical trial
- •? Patients who need hormone therapy after intrauterine surgery
- •? Patients who had GnRH hormone therapy within 3 months before screening
- •? Patients who have local or systemic infection, endometrial cancer (uterus and endometrium, cervical cancer) and excessive uterine bleeding
- •? Patients who have abnormal liver function, abnormal kidney function, abnormal hemostatic function
- •? Patients who are applied anti-coagulants or who took systemic steroids within 1 week before surgical operation
- •? Patients with immunosuppression or autoimmune diseases
- •? Patients with uncontrolled diabetes
- •? Patients with hypersensitivity to the medical device for clinical trials
- •? Patients who have participated in other clinical trials within 30 days prior to participating in this clinical trial
- •? In the case that investigators made a decision that a person is inappropriate to participate in the clinical trial
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