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: 2024年8月19日

试验速览

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•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

•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.

发起方

Meril Life Sciences Pvt Ltd