Prospective, Multicentre Feasibility Study of Remote Colon Capsule Endoscopy Using the OMOM CC100 System

Background and Aims: Colon capsule endoscopy (CCE) provides a non-invasive alternative to traditional colonoscopy. This study evaluated the feasibility, safety, diagnostic yield (DY), and patient satisfaction of the OMOM CC100 CCE system, with special focus on fully remote (n = 30) and partially remote (n = 89) administration across four centres to advance decentralised models. Methods: This prospective, investigator-initiated, international multicentre feasibility study enrolled 119 patients aged 18-75 years at centres in Denmark, Sweden, Portugal, and Poland from July 2024 to May 2025. Indications included rectal bleeding, iron-deficiency anaemia, a positive faecal immunochemical test, changes in bowel habit, suspected inflammatory bowel disease (IBD), post-polypectomy or colorectal cancer (CRC) surgery surveillance, and a family history of CRC. The OMOM CC100 capsule was employed with a standardised bowel preparation regimen. Administration was fully remote in Denmark using the IntelliGI™ platform and partially remote (clinic ingestion, home completion) at the other sites. Primary outcomes encompassed procedure feasibility, completion rate (capsule excretion or anal verge visualisation), bowel cleanliness (Leighton-Rex scale ≥ 3), diagnostic yield, and patient satisfaction. Secondary measures included transit times, adverse events, and technical failures. Results: Median age was 55.7 years (65 males, 54 females). Overall completion rate was 79%, varying by centre: Sweden (90%), Portugal (81%), Denmark (80%), and Poland (63%). Adequate bowel cleanliness was achieved in 71% of cases. Diagnostic findings included polyps (25 patients), angioectasia (20), diverticulosis (17), and mucosal inflammation (17); 42% were normal. Fully remote administration yielded 80% completion and 89.7% satisfaction. No serious adverse events occurred; overall satisfaction was 81%, with 87% preferring home-based procedures. Conclusions: The OMOM CC100 CCE system is feasible, safe, with DY comparable to established systems. IntelliGI™-enabled remote administration promotes decentralised care, enhancing accessibility.