Prospective, Multicentre Feasibility Study of Remote Colon Capsule Endoscopy Using the OMOM CC100 System
(2026) In Diagnostics 16(1).- Abstract
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... (More)
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.
(Less)
- author
- organization
- publishing date
- 2026-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- administration, capsule endoscopy, colonoscopy, diagnostic yield, patient satisfaction
- in
- Diagnostics
- volume
- 16
- issue
- 1
- article number
- 20
- publisher
- MDPI AG
- external identifiers
-
- pmid:41515515
- scopus:105027253784
- ISSN
- 2075-4418
- DOI
- 10.3390/diagnostics16010020
- language
- English
- LU publication?
- yes
- id
- 08a16c3b-619c-4ce4-824d-6b031c74d1cf
- date added to LUP
- 2026-03-17 13:32:58
- date last changed
- 2026-03-31 14:25:42
@article{08a16c3b-619c-4ce4-824d-6b031c74d1cf,
abstract = {{<p>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.</p>}},
author = {{Agache, Alexandra and Toth, Ervin and Qvist, Niels and Mascarenhas, Miguel and Marlicz, Wojciech and Schelde-Olesen, Benedicte and Mascarenhas-Saraiva, Miguel and Marlicz, Maria and Johansson, Gabriele Wurm and Nemeth, Artur and Koulaouzidis, Anastasios}},
issn = {{2075-4418}},
keywords = {{administration; capsule endoscopy; colonoscopy; diagnostic yield; patient satisfaction}},
language = {{eng}},
number = {{1}},
publisher = {{MDPI AG}},
series = {{Diagnostics}},
title = {{Prospective, Multicentre Feasibility Study of Remote Colon Capsule Endoscopy Using the OMOM CC100 System}},
url = {{http://dx.doi.org/10.3390/diagnostics16010020}},
doi = {{10.3390/diagnostics16010020}},
volume = {{16}},
year = {{2026}},
}