Feasibility study of a single-use balloon-assisted robotic colonoscope in healthy volunteers

Abstract

Background and study aims: Despite its widespread adoption, colonoscope still has its limitations. Advancement is often limited by the looping of colon. The isolation of SARS-CoV-2 in stool raises concern for the risk of disease transmission. A single-use robotic colonoscope, the NISInspire-C System, that features a balloon-suction anchorage mechanism was developed to address these.

Methods: The NISInspire-C balloons are designed to provide anchorage for straightening of the colon during advancement. Angulation at the bending section is tendon-wire driven by servo mechanisms integrated into a robotic control console. This was a pilot, prospective trial to evaluate the safety and feasibility of this system. Healthy volunteers underwent examination with the NISInspire-C, followed by the conventional colonoscope. The procedure time, cecal intubation rates (CIR), complications, and level of pain were measured.

Results: A total of 19 subjects underwent the examination. The cecal intubation rate was 89.5 % (17/19) and the overall time-to-cecum was 26.3 minutes (SD: 17.9 mins). There were no procedure-related complications. Polyps were detected in seven of 19 (36.8 %) subjects during the NISInspire-C procedure. Three more subjects were found to have adenomatous polyps with the conventional colonoscope. There was minimal variation in level of pain during the procedures with the two colonoscopes.

Conclusion: The single-use robotic colonoscope NISInspire-C is a safe and feasible alternative to the conventional colonoscope. Further technical refinement is needed to improve the CIR. This study was limited by its small sample size.