Activ Surgical today announced the completion of the first in-human surgery clinical trial using its technology-as-a-service bundle, including the ActivInsights augmented reality-based software suite and the ActivSight imaging module.
The Boston-based digital surgery company claimed that it completed the world’s first autonomous robotic surgery of soft tissue in 2018. Activ Surgical said it is using artificial intelligence and augmented reality (AR) to improve surgical vision and make procedures safe, smart, and accessible to all.
The patented ActiveEdge software is being designed to reduce preventable errors by enhancing a surgeon’s intraoperative decision making via the aggregation of data from around the world.
Clinical trials in Texas
The study occurred at The University of Texas Health Science Center at Houston (UTHealth Houston). Dr. Erik Wilson, professor in the Department of Surgery at McGovern Medical School at UTHealth and a bariatric, endoluminal, and robotic general surgeon, and Dr. Shinil Shah, associate professor at UTHealth Houston and a general surgeon with expertise in advanced gastrointestinal surgery, led the procedure.
The safety and feasibility study was conducted across bariatric, colorectal, and gallbladder procedures—surgeries in which intraoperative assessment of perfusion and anatomic structures are critical to prevent costly and life-threatening complications.
During the study, Dr. Wilson and Dr. Shah conducted a number of procedures using ActivInsights and ActivSight. Together, the products delivered perfusion view insights, which allowed Dr. Wilson and Dr. Shah the ability to see blood flow and perfusion in real time, without the use of traditional dyes.
“Patient safety is always our No. 1 priority in the operating room,” said Dr. Wilson. “Our study using the ActivInsights AR-based software suite and the ActivSight imaging module revealed no safety issues and showed it has the potential to improve patient outcomes and reduce surgical complications. It was seamless for our team to use and provided physiological information in real-time during these first in-human procedures.”
More imaging tests to come
The UTHealth Houston study’s procedures were performed at Memorial Hermann-Texas Medical Center and Memorial Hermann Sugar Land Hospital. The study with UTHealth Houston is the first of several in-human trials Activ Surgical has planned around the world with healthcare systems and surgeons in 2021.
In April, the U.S. Food and Drug Administration (FDA) granted Activ Surgical clearance for the ActivSight interoperable imaging module. The company, which is a member of MassRobotics, raised $45 million in Series B funding in September.
“We are grateful to Dr. Wilson and Dr. Shah to be the first to participate in these imperative in-human safety and feasibility studies,” said Todd Usen, CEO of Activ Surgical. “While HD and 4K have taken what a physician or a television viewer can see and enhances it, the ActivInsights software suite and ActivSight imaging module takes this advancement a step further by allowing surgeons to see what they currently cannot via present-day technology.”
“These trials, coupled with our recent clearance from the FDA, are critical steps in the rollout of our technology that will improve patient outcomes and safety in the OR and help to democratize surgical care across the globe,” he said.
Activ Surgical said it expects its software suite to be commercially available to surgeons around the world in 2022.
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