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

Area of Science:

• Gastroenterology
• Medical Devices
• Endoscopy

Background:

• Colon capsule endoscopy (CCE) offers a non-invasive alternative to conventional colonoscopy.
• Decentralized care models are emerging for improved accessibility in gastrointestinal diagnostics.

Purpose of the Study:

• To evaluate the feasibility, safety, diagnostic yield, and patient satisfaction of the OMOM CC100 CCE system.
• To assess the efficacy of fully and partially remote administration for advancing decentralized CCE models.

Main Methods:

• A prospective, international multicenter feasibility study involving 119 patients (aged 18-75).
• Utilized the OMOM CC100 capsule with standardized bowel preparation.
• Compared fully remote (IntelliGI™ platform) and partially remote administration across four European centers.

Main Results:

• Overall completion rate was 79%, with adequate bowel cleanliness in 71% of patients.
• Diagnostic yield included polyps (25), angioectasia (20), and mucosal inflammation (17); 42% of examinations were normal.
• Fully remote administration achieved 80% completion and 89.7% satisfaction; overall patient satisfaction was 81%.

Conclusions:

• The OMOM CC100 CCE system is feasible, safe, and offers a diagnostic yield comparable to existing systems.
• IntelliGI™-enabled remote administration facilitates decentralized CCE, improving accessibility and patient preference for home-based procedures.