Safety and efficacy of a novel miniaturized robotic assisted surgery system in hysterectomy: a prospective, investigational device exemption clinical trial.

Ricardo Estape¹, Piet Hinoul², Greg Heidrick³, Todd Martin³, Florence Beck⁴, Ty B Erickson⁵, Jean Dubuisson⁶, Nadia Gomez⁵

¹Institute for Gynecologic Oncology, HCA, Miami, FL, USA. ricardo.estape@hcahealthcare.com.

²Medical and Clinical Affairs, Virtual Incision, Lincoln, NE, USA.

³Bryan Health, Lincoln, NE, USA.

⁴Regulatory and Clinical Affairs, Virtual Incision, Lincoln, NE, USA.

⁵Gynecology, University of Nevada, Las Vegas, NV, USA.

⁶Gynecology, HUG - Hopitaux Universitaires de Genève, Geneva, Switzerland.

PubMed DOI

Abstract

To evaluate safety and effectiveness of the first-in-kind miniaturized surgical robotic platform, the MIRA Surgical System, in patients presenting with an indication for benign hysterectomy. A prospective, multi-center, multi-operator, non-randomized, consecutively enrolled Investigational Device Exemption Clinical Trial. Five surgeons participated across three types of institutions. Thirty-five p…

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