The postmarket trial is designed to evaluate the performance of a surgical robotic system in free flap reconstruction and lymphatic repair procedures.
Medical Microinstruments Inc (MMI) has enrolled the first patient in its PRECISE clinical study, a prospective, multi-center US trial focused on robotic-assisted microsurgery. The postmarket study will evaluate the performance of the company’s Symani Surgical System in free flap reconstruction and lymphatic repair procedures.
The first patient was enrolled at a nonprofit academic healthcare organization in Los Angeles, officially launching the study.
“The PRECISE study is a milestone for the broader field of reconstructive microsurgery,” says Mark Toland, CEO of MMI, in a release. “It reflects MMI’s commitment to building the clinical evidence needed to expand patient access to advanced microsurgical care and validate the long-term value of robotic assistance in complex procedures.”
Study Design and Clinical Endpoints
The study aims to enroll up to 455 patients across multiple cancer centers in the US. It will consist of two patient cohorts—free tissue transfer and lymphatic repair—which will be followed for 30 days and three months, respectively. Key clinical endpoints include anastomosis patency, ischemia time, limb volume reduction, freedom from device-related adverse events, and quality-of-life outcomes.
“PRECISE fills a critical gap for the microsurgical community by providing real-world clinical evidence on robotic microsurgical outcomes in patient populations where precision and long-term results matter the most,” says Bohdan Pomahac, MD, national principal investigator and division chief of plastic and reconstructive surgery at Yale Surgery and Smilow Cancer Hospital, in a release.
Technology and Regulatory Status
The Symani Surgical System is currently the only commercially available surgical robot designed specifically for microsurgery, according to a release from the company. The system features proprietary wristed microinstruments, along with tremor-reducing and motion-scaling capabilities, intended to improve precision in delicate, open surgical procedures.
The platform is authorized for use in the US by the Food and Drug Administration and is a CE-Marked medical device in Europe. According to the company, this study is part of a broader clinical initiative to strengthen the evidence base for robotic technology in microsurgical applications.
ID 385627876 © Iryna Kushnarova | Dreamstime.com
