Computer-Assisted Colonoscopy (the NeoGuide System): Results of the First Human Clinical Trial

Abstract

Background: Unsedated colonoscopy is an uncomfortable procedure for most patients. The majority of procedures in most centers are performed using moderate sedation with an anxiolytic medication, narcotic analgesia, a combination of both, or deep sedation (e.g., propofol). Discomfort during colonoscopy is largely related to looping of the colonoscope, which displaces the colon from its native configuration and stretches attachments to the mesentery (Shah, et al. Endoscopy 2002; 34(6):435-440). A novel computer-assisted colonoscope (NeoGuide Systems, Inc., Los Gatos, CA) utilizes a fully articulated, computer-controlled insertion tube. On manual insertion of the colonoscope, the position and angle of the initial segment located at the distal tip is encoded into a computer algorithm. Each successive segment is instructed by the system to make a similar angle when it reaches the same point in the colon. The insertion tube thus advances through the colon in a “follow-the-leader” manner. Methods: This clinical trial was designed as a prospective, non-randomized, un-blinded, feasibility study. Five physicians of varying levels of experience participated in the study. Two-person colonoscopy was performed as per the routine of the endoscopy unit with one physician controlling the steering mechanism and the second inserting the colonoscope. Results: Ten consecutive patients (6/M; 4/F; age range 19-80) meeting inclusion criteria for screening or diagnostic colonoscopy were enrolled in the study. The cecum was reached in all ten consecutive patients and the terminal ileum in nine. Findings included diverticular disease in two cases and multiple colonic polyps in two cases. Polyps were removed using standard endoscopic techniques. Although no attempt was made to reach the cecum as rapidly as possible in any case, the cecum was reached in 5-6 minutes in three of the ten cases. Post procedure assessment at discharge, 48 hours, and 30 days revealed no complications or adverse effects. When contacted the evening after the procedure, all ten patients indicated their willingness to undergo the procedure again using the computer-assisted colonoscope. Conclusions: In this limited, first of its kind feasibility study, the computer-assisted colonoscope was shown to perform colonoscopy safely and effectively. The colonoscope's unique design limited loop formation during colonoscopy. The cecum was reached in all patients and all patients reported their willingness to undergo the procedure again using this novel device. Large scale clinical trials are indicated.