Dive Brief:
- Endoquest Robotics said it will launch a clinical trial for robotic colorectal surgery early next year at five U.S. hospitals after receiving an investigational device exemption from the Food and Drug Administration.
- The Paradigm study will evaluate the safety and effectiveness of Endoquest’s robotic endoscopic system to remove colorectal lesions.
- The trial will enroll 50 patients at Brigham and Women’s Hospital in Boston; Mayo Clinic in Scottsdale, Arizona; Cleveland Clinic; Adventhealth in Orlando, Florida, and HCA Healthcare in Houston, the company said Tuesday.
Dive Insight:
Houston-based Endoquest is developing a robotic surgical system that is meant to be less invasive by enabling navigation through the body’s natural orifices. The single-incision surgical approach could allow new types of procedures to be performed and improve patient outcomes, with less tissue trauma and scarring, according to the company.
“This technology represents the evolution we have been waiting for to finally perform endoluminal surgery, which could redefine what’s possible in minimally invasive colorectal procedures and potentially allow a significant number of patients to avoid invasive operations like colectomies,” Todd Wilson, Endoquest’s chief medical officer, said in a statement.
In January, Endoquest’s system was accepted into the FDA’s Safer Technologies Program for devices expected to improve the safety of available treatment options. Participants in the program benefit from a streamlined development and review process with the goal of speeding patient access to new technologies.
Endoquest’s pivotal clinical study will evaluate the robotic system in endoluminal procedures in the rectum and colon. Endoluminal refers to the inside of the intestines.
A pre-clinical study found the system had better procedure outcomes, a shorter learning curve and reduced procedure times compared to the conventional technique for endoscopic dissection of lesions in the colon.
The privately held company raised $42 million in a December 2023 financing round led by CE Ventures and McNair Interests.
