Medtronic has started its Embrace Gynecology investigational device exemption (IDE) U.S. clinical study. The study will assess its Hugo robotic-assisted surgery (RAS) system in robotic-assisted gynecological procedures.

The prospective multicenter study will evaluate the Hugo RAS’ safety and effectiveness when used during radical, modified radical, or total hysterectomy procedures—including those being treated for malignancies. The study will enroll up to 70 subjects at up to five U.S. hospitals.

The first procedures, total hysterectomies, were successfully completed at AHN West Penn Hospital in Pittsburgh, Pa., by Dr. Sarah Crafton and Dr. Eirwen Miller, Embrace Gynecology study surgeons at Allegheny Health Network.

“We are excited to initiate this important clinical study, which aims to investigate surgical treatment options for women in the U.S.,” said Dr. Emma Rossi, Embrace Gynecology national principal investigator and associate professor of Obstetrics and Gynecology at Duke University in Durham, N.C. “In my experience, women facing a gynecologic diagnosis want two things: to effectively treat their condition, and to get back to their full lives as quickly as possible. Robotic-assisted surgery helps make that possible.”

Embrace Gynecology is the third IDE study for Hugo in the U.S. The other two—Expand URO and Enable Hernia—have both met primary safety and effectiveness endpoints.

In July, positive results from a company-sponsored study of Hugo for benign gynecologic procedures were shared at the Society of Robotic Surgery congress. Medtronic’s first U.S. submission for a urology indication is under review by the U.S. Food and Drug Administration (FDA) and is anticipated later in the company’s current fiscal year, followed by planned indication expansions into hernia repair and gynecology.

“The study name, Embrace, reflects our deeply felt compassion and care for patients and our commitment to providing access to less invasive treatment options for women,” said Dr. James Porter, chief medical officer of Medtronic’s Robotic Surgical Technologies and Digital Technologies business. “We are grateful for the strong partnership with clinical teams at our study sites and share their excitement about this rigorous scientific study that is helping to usher in a new era of choice for patients in the U.S.”