Introduction
Robotic surgical platforms have become the new standard of care in many specialties. Robotic endoscopic platforms, however, remain limited despite potential enhancements in precision, control and ergonomics. In this first-in-human study, we evaluated the safety and efficacy of the Triton™ robotic colonoscopy system, which 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.
Aims & Methods
This was a prospective single arm, non-randomized single site first-in-human study. Three endoscopists, highly experienced in manual colonoscopy, performed all procedures. The study included adults ≥22 years with indication for screening, surveillance, or diagnostic colonoscopy. The study consisted of two phases: Phase A served as a lead-in to evaluate safety in 10 patients. This was a tandem design with manual colonoscopy performed first followed by robotic colonoscopy excluding any polypectomy. Phase A primary endpoint was major adverse events, including perforation, bleeding and hospitalization within 48 h. Phase A secondary endpoints were delayed perforation and/or bleeding within 14 days. Phase B evaluated safety and efficacy in 40 patients with only robotic colonoscopy including removal of polyps < 2cm. Phase B primary endpoints were successful completion of colonoscopy and major adverse events. Phase B secondary endpoints were need for repositioning, Adenoma Detection Rate (ADR), successful polypectomy, time to cecum, mucosal injury score graded from 1–5 (1 = erythema/bruising; 5 = full thickness injury), and physical/mental load using the NASA task load index.
Results
No adverse events occurred in phases A or B. Cecal intubation was achieved in 100% of cases (10/10 Phase A; 40/40 Phase B). All procedures were completed in left-lateral position without need for repositioning, abdominal pressure, or conversion to manual colonoscopy. In Phase B, 79 polyps were detected. ADR was 54.2% and polyp detection rate was 67.5%. 77/77 polypectomies were completed successfully; 2 lesions measuring >2 cm were not removed as per protocol. Median time to cecum was 13 minutes (Range 5-36 mins). Amongst the mucosal injury findings, all were grade 1, except 3 were rated as grade 2 and 1 as grade 3; none were ≥ grade 4 and no intervention was required. Physical/mental load was rated as low (composite: median 33 [IQR 15-41] on a scale of 0-600).
Conclusion
In this 50-patient first-in-human study, the Triton™ system demonstrated excellent safety and feasibility, with 100% cecal intubation and no adverse events after 14-days follow-up. 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.
Disclosure
Jason Samarasena: Consultant/Speaker: Olympus, Fujijilm, Applied Medical, Neptune, Boston Scientific, Medtronic, Cook Medical; Research support: Cook Medical; Educational grant: Cook Medical.
Marcin Romańczyk - Olympus, Medtronic - consulting; Odin Vision, – consulting, device loan
