A robotic colonoscopy system has been shown to be safe and feasible in the first-in-human CARE study, with successful completion of the procedure achieved in all cases and no major adverse events (AEs).
Named Triton, the colonoscopy system uses “proprietary dual dynamic rigidization technology that enables shape-controlled navigation, as well as precise tip deflection and roll using a remote-controlled colonoscope and overtube,” according to lead investigator Dr Jason Samarasena from the University of California – Irvine in the US.
During a playback of a procedural video, Samarasena highlighted Triton’s ability to maintain exceptional stability and perform movements with a level of precision difficult to achieve in manual colonoscopy. “The scope can retroflex very easily and rotate well over 360 degrees with the push of a button.”
The enhanced control provided by Triton, he said, facilitates more thorough visualization and effortless entry into the ileocecal valve.
Successful cecal intubation
CARE was a single-arm, single-site study involving 50 adults at least 22 years of age who had indication for screening, surveillance, or diagnostic colonoscopy. The study consisted of two phases.
Phase A included 10 individuals (mean age 43.2 years, 80 percent female, mean BMI 26.7 kg/m2) and served as a lead-in, with a tandem design. Manual colonoscopy was performed first, followed by robotic colonoscopy, excluding polypectomy. The primary endpoint was major AEs, including perforation, bleeding, and hospitalization within 48 h. Secondary endpoints were delayed perforation and/or bleeding within 14 days.
Phase B assessed the safety and efficacy of performing colonoscopy with Triton, including removal of polyps <2 cm, in 40 individuals (mean age 48.6 years, 40 percent female, mean BMI 27.5 kg/m2). The primary endpoints were major AEs and successful colonoscopy completion. Secondary endpoints included need for patient repositioning, adenoma detection, successful polypectomy, mucosal injury score, and physical/mental load using the NASA task load index, among others.
In both phases, cecal intubation was achieved in 100 percent of cases, and no AEs occurred. All procedures were completed in left-lateral position without need for repositioning, abdominal pressure, or conversion to manual colonoscopy. [Romanczyk M, et al, DDW 2026]
In phase B, median time to cecum was 13 min (range, 5–36 min). According to Samarasena, a significant portion of the procedure time was dedicated to exploring and understanding optimal techniques for advancement, reduction, and visualization.
A total of 79 polyps were detected. The adenoma detection rate was 54.2 percent, while the polyp detection rate was 67.5 percent. Polypectomy success rate was 100 percent for polyps <2 cm.
For mucosal injuries, three were rated as grade 2, one was grade 3, and 59 were grade 1. None of the injuries were grade ≥4, and no intervention was required.
Ergonomic experience
“The stability provided by dual dynamic rigidization with robotic precision enabled comprehensive inspection, effective polyp detection, and safe resection, while providing a comfortable ergonomic experience,” Samarasena said.
Triton had a very low score on the NASA task load index compared with manual colonoscopy (36 vs 105.4), indicating its ergonomic advantage. This was true for all the index domains, such as physical demand (5.6 vs 22.8), effort (9.5 vs 25.8), temporal demand (3.4 vs 11.8), mental demand (10.8 vs 24.2), and frustration (7.1 vs 22.6).
“The reason for [the lower scores] is, when you operate Triton, you are very comfortable sitting in a chair with this modified video game controller in your hand, controlling all the aspects of the colonoscope with buttons on the controller. So, it really is a pleasure to take care of a patient in such a relaxed, stable, and controlled manner,” Samarasena noted.