Diagnostic Performance and Feasibility of the CC100 Colon Capsule Endoscopy System: A Prospective Multicenter Study

Colorectal cancer screening continues to rely on conventional colonoscopy, yet its invasiveness, limited accessibility, and growing procedural demand constrain large-scale implementation. Colon capsule endoscopy (CCE) offers a minimally invasive alternative, but its clinical adoption has been hampered by incomplete examinations and concerns regarding diagnostic accuracy.

In this prospective multicenter diagnostic accuracy study conducted at three tertiary hospitals in Chongqing, China, participants underwent CC100 colon capsule endoscopy followed by conventional colonoscopy as the reference standard. Primary outcomes included complete colonic visualization and diagnostic agreement for colorectal lesion detection. Secondary outcomes assessed lesion-specific performance and safety.

Among 136 participants completing both procedures, complete colonic visualization was achieved with CC100 CCE in 124/136 participants (91.18%), whereas conventional colonoscopy was completed in 136/136 participants (100%). No capsule retention or procedure-related adverse events occurred. Overall agreement with colonoscopy for colorectal lesion detection was 83.82% (κ = 0.673). For clinically relevant polyps ≥6 mm, CC100 demonstrated a sensitivity of 86.67% and a specificity of 98.63%.

This prospective multicenter study demonstrates that a next-generation CCE system can achieve acceptable examination completeness and clinically meaningful diagnostic concordance with colonoscopy.