Computer-assisted colonoscopy (the NeoGuide Endoscopy System): results of the first human clinical trial ("PACE study")

Abstract

Objectives: Unsedated colonoscopy is an uncomfortable procedure for most patients. 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. A novel computer-assisted colonoscope utilizes a fully articulated, computer-controlled insertion tube. On manual insertion of the colonoscope, the position and angle of the scope's tip are encoded into a computer algorithm. As the colonoscope is advanced, the computer directs each successive segment to take the same shape that the tip had at a given insertion depth. The insertion tube thus changes its shape at different insertion depths in a "follow-the-leader" manner.

Methods: This initial clinical trial with this novel colonoscopy system was designed as a prospective, nonrandomized, unblinded, feasibility study. Three physicians of varying levels of experience participated in the study.

Results: Eleven consecutive patients (seven men, four women, age range 19-80) meeting inclusion criteria for screening or diagnostic colonoscopy were enrolled in the study. The cecum was reached in 10 consecutive patients (100%). Findings included diverticular disease in two cases and multiple colonic polyps in two cases. Postprocedure assessment at discharge, 48 h, and 30 days revealed no complications or adverse effects. Physician satisfaction and patient acceptance of this new technique were high.

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. Large-scale clinical trials are indicated.