The first multicenter clinical trial testing robotic mastectomy is starting in the United States. It is conducted by City of Hope, a private, non-profit clinical research center in California. Previously Food and Drug Administration (FDA) warned that the safety and effectiveness of robotic surgical devices for mastectomy “have not been established” and robots are not approved for the prevention or treatment of breast cancer.
City of Hope, a private, not-for-profit clinical research center in Duarte, California, is launching the first multicenter clinical trial in the United States to test robotic mastectomy. Patients with early-stage breast cancer are eligible to participate in the trial, in which half of the participants will undergo robotic mastectomy and the other half will undergo traditional open surgery, Becker’s Hospital Review reports.
Robotic technology allows mastectomies to be performed with a single incision, making the procedure less invasive than traditional ones, the research center said in a press release. The clinic’s surgeons have already performed hundreds of thousands of robotic procedures not related to mastectomies. If the test results are positive, then robotic mastectomy will be introduced into clinical practice in the future.
In February 2019 FDA issued a warning that the safety and effectiveness of robotic surgical devices for mastectomy “have not been established” and robots are not approved for the prevention or treatment of breast cancer. Several prospective trials of robotic nipple-sparing mastectomy were conducted in the United States in 2021. However, according to Medscape, in each case the study design focused more on cosmetic effects rather than assessing effectiveness in terms of cancer treatment. In addition, the incidence of adverse events was studied only in the short term: for up to six weeks after surgery. In addition, none of the studies were randomized. At the same time, traditional open mastectomy optimally ensures removal of the entire tumor, which reduces the risk of recurrence, critics noted.
As of July 2021, only about 150 robotic mastectomies have been performed worldwide, mostly in Italy, France, Taiwan and Korea.