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.

Capsule endoscopy (CE) is evolving from a primarily small-bowel imaging modality into a broader diagnostic platform that increasingly incorporates artificial intelligence (AI), robotic technologies, biosensing capabilities, and decentralized models of care. The REFLECT symposium brought together an international, multidisciplinary audience of clinicians, engineers, scientists, and healthcare stakeholders to critically evaluate the present and future role of CE across a range of gastrointestinal (GI) applications, including inflammatory bowel disease, GI bleeding, coeliac disease, and colorectal cancer screening. Discussions explored the clinical impact of panenteric and colon capsule endoscopy, the potential of AI to enhance diagnostic performance and streamline workflows, innovations in capsule hardware, and the design of patient-centred diagnostic pathways. While conventional endoscopy continues to serve as the benchmark in many clinical scenarios, CE was recognized for its ability to improve access, acceptability, and scalability when deployed in appropriately selected populations. The symposium also identified key barriers to broader implementation, such as reinvestigation rates, absence of standardized quality indicators, limited real-world evidence for AI tools, and ongoing economic and environmental challenges. Overall, the meeting highlighted the importance of gradual, evidence-driven integration of CE, supported by robust validation, standardized metrics, close clinician-engineer collaboration, and meaningful incorporation of patient experience, to support the development of a safe, equitable, and sustainable pathway.

Background/Objectives: Colonoscopy is the standard examination for many symptomatic patients referred for lower-gastrointestinal investigation, but it is resource-intensive and may be a burdensome experience. Colon capsule endoscopy (CCE) offers a minimally invasive, sedation-free first-line examination, although clinically important findings, inadequate cleansing or incomplete transit can generate downstream colonoscopy. DanCap aims to compare the costs and clinical consequences of a CCE-first pathway with routine conventional colonoscopy (CC). Methods: DanCap is a single-centre, cluster-allocated crossover trial at Odense University Hospital, Denmark. General practice clinics follow CCE or CC according to the parity of their pre-existing provider number, with pathways crossing after 200 consecutive CCE participants; no trial-generated random allocation sequence is used. Eight hundred symptomatic adults aged >18 years referred for expedited lower-gastrointestinal investigation are planned. CCE participants with suspected cancer, any polyp ≥6 mm, inadequate cleansing or an incomplete examination are referred for colonoscopy. The primary outcome is pathway cost. Registered secondary outcomes and prespecified process measures include polyp and colorectalcancer detection, examination quality, reinvestigation and patient-reported consequences. FIT and microbiome are registered secondary outcomes; participation in the substudy is optional and the analyses are exploratory within the CCEpathway. Primary analyses will follow the assigned pathway and account for GP clinic clustering, period and allocation sequence. Expected Results: The trial will quantify the resource use and clinical consequences of implementing CCE in routine symptomatic practice. Conclusions: DanCap is intended to inform decisions about CCE pathway implementation rather than to establish unbiased whole-cohort test sensitivity or specificity. Trial registration: ClinicalTrials.gov NCT06475560; first submitted 20 June 2024 and first posted 26 June 2024. Recruitment began on 27 November 2024; the registry listed the study as recruiting when last updated on 19 March 2026.

The fifth annual REFLECT (The futuRE oF MinimalLy InvasivE GI and Capsule diagnosTics) symposium, held in October 2024 in Nyborg, Denmark, focused on advancements in minimally invasive gastrointestinal (GI) diagnostics, particularly capsule endoscopy (CE) technologies. Key discussions included clinical updates, innovations in hardware and software, and the growing role of colon CE (CCE) in colorectal cancer screening. The event provided a platform for clinicians, engineers, industry representatives, and scientists to exchange knowledge and present the latest advancements in the field. Discussions covered clinical studies, future research protocols, and technological innovations, with also a notable focus on commercial solutions and expansion of the implementation of capsule endoscopy. The symposium also highlighted the significance of predictive models for patient selection and developments in panenteric CE. Innovative technologies presented included robotics for drug delivery and magnetic endoscopic guidance systems. AI advancements were discussed for their potential to reduce diagnostic fatigue and standardize image interpretation, but ethical concerns and the need for transparent algorithms remain. The importance of multidisciplinary collaboration was emphasized to bridge innovation and clinical practice. Home-based CCE delivery emerged as a promising model, despite mixed results from environmental impact assessments. Overall, REFLECT 2024 reinforced the clinical utility and challenges of capsule-based diagnostics, advocating for ongoing interdisciplinary research to support safe and effective integration into healthcare systems.

Introduction: A large bowel cancer chemoprevention potential has been demonstrated by the consumption of carrots, which represent the major dietary source of polyacetylenes. Their interaction with cancer cells and enzyme systems of animals and humans has been systematically investigated over the last 15 years and has now been characterised as anti-inflammatory compounds with antineoplastic effect. Our objective is to investigate whether selected carrot species with a high content of the polyacetylenes falcarinol (FaOH) and falcarindiol (FaDOH) prevent neoplastic transformation and growth in humans, without side effects. Methods and analysis: We will conduct a multicentre prospective binational (Denmark and Sweden) randomised controlled trial, with the aim to test the clinical effects of adjuvant treatment with carrot juice in patients who had an excision of high-risk colon adenomas. Patients from six centres will be randomised to receive either anti-inflammatory juice made of carrots high in FaOH and FaDOH or placebo. We will compare the proportion of participants with recurrent adenoma and mean size of them, found in the 1-year follow-up colonoscopy between the two randomised groups. Ethics and dissemination: Informed written consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee in Denmark (ref. S-20230072) and Sweden (ref. 2024-04732-01 ). After completion of the trial, we plan to publish two articles in high-impact journals: one article on primary and secondary outcomes, respectively. Trial registration number: NCT06335420 .

The purpose of this position statement is to propose expected performance values for artificial intelligence (AI) applications in colon capsule endoscopy (CCE), with emphasis on detection, characterization, localization, reporting, and downstream management of colonic neoplasia. The task force was created within the Artificial Intelligence in Capsule Endoscopy (AICE) consortium project work and drew on members of the international Capsule Endoscopy Research (iCARE) group for development, review, consensus voting, and final approval. These values are intended as consensus-based benchmarks for research, validation, and future clinical translation, while explicitly acknowledging the limited availability of robust CCE-specific clinical evidence. The task force included CCE experts, technical experts, patient representatives, and an ethicist, and defined expected values using existing endoscopy quality frameworks, available capsule endoscopy literature, relevant proxy evidence from colonoscopy, and structured Delphi consensus. Super agreement of more than 80% across up to three Delphi voting rounds was required for consensus. The agreed statements address candidate selection, assessment of mucosal visualization and procedure completeness, landmark and segment recognition, polyp matching, lesion size estimation, reading-time reduction, detection of colorectal neoplasia, false-positive burden, risk stratification for subsequent procedures, prediction of advanced pathology, urgency categorization, and automated report generation. The proposed thresholds should not be interpreted as definitive requirements for immediate clinical adoption. Instead, they identify minimum expected and aspirational values that future systems should be tested against in prospective, externally validated, full-video CCE studies.