CTRI/2024/07/071348尚未招募4 期
igating Clip PMS Study: A prospective, single-arm, multi-centre, observational, real-world, post-market surveillancestudy to evaluate the safety and efficacy of MIRUS™ LIGATING CLIP. - NI
Meril Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1 The subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form.
- •2 In the case of a subject and LAR being illiterate, a literate impartial witness is required during consenting.
- •3 If the subject is not able to write on behalf of the subject, the subjects LAR (Legally acceptable representative) can fill out the informed consent.
- •4 The subject is willing and able to comply with postoperative scheduled clinical evaluations.
- •5 Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •6 Subject must be treated with MIRUS™ LIGATING CLIP.
- •7 The subject must receive treatment for securely gripping the vessel or tissue to provide complete occlusion atraumatically
排除标准
- •1 Without informed consent, the subject is not eligible for the study.
- •2. Patients undergoing fallopian tube ligation or renal artery ligation are not eligible for the use of MIRUS™ LIGATING CLIP.
研究者
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