Clinical trial · Interventional
Comparison of Two Devices During Colonoscopy
Endocuff vs Transparent Cap To Increase Adenoma Detection Rate During Colonoscopy
NCT03197987CI-TRIAL-00035680COLONAUXcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy. In this study we compare two devices: Endocuff (TM) and cap that can increase the adenoma detection rate during colonoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cap | Device | — | UNRESOLVED |
| Endocuff | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endocuff colonoscopy
- description
- Endocuff-assisted colonoscopy
- interventionNames
- Device: Endocuff
- type
- ACTIVE_COMPARATOR
- label
- Cap colonoscopy
- description
- Cap-assisted colonoscopy
- interventionNames
- Device: cap
Primary outcomes (1)
- measure
- Adenoma detection rate
- timeFrame
- 7 days
- description
- number of patients with at least one adenoma/total number of patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients who are attending for screening, surveillance or diagnostic colonoscopy. Exclusion Criteria: * patients with absolute contraindications to colonoscopy; * patients with established or suspicion of large bowel obstruction or pseudo-obstruction; * patients with known colonic strictures; * patients with a known severe diverticular segment (that is likely to impede colonoscope passage); * patients with active or known colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis); * patients lacking capacity to give informed consent; * patients on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure; * patients who are attending for a therapeutic procedure or assessment of a known lesion, or submitted for rectoscopy or rectosigmoidoscopy; * examination performed by a non-expert colonoscopist; * pregnancy.
References
Publications (13)
- BACKGROUNDKaminski MF, Regula J, Kraszewska E, Polkowski M, Wojciechowska U, Didkowska J, Zwierko M, Rupinski M, Nowacki MP, Butruk E. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med. 2010 May 13;362(19):1795-803. doi: 10.1056/NEJMoa0907667. PMID 20463339
- BACKGROUNDFloer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014. PMID 25470133
- BACKGROUNDvan Doorn SC, van der Vlugt M, Depla A, Wientjes CA, Mallant-Hent RC, Siersema PD, Tytgat K, Tuynman H, Kuiken SD, Houben G, Stokkers P, Moons L, Bossuyt P, Fockens P, Mundt MW, Dekker E. Adenoma detection with Endocuff colonoscopy versus conventional colonoscopy: a multicentre randomised controlled trial. Gut. 2017 Mar;66(3):438-445. doi: 10.1136/gutjnl-2015-310097. Epub 2015 Dec 16. PMID 26674360
- BACKGROUNDMarsano J, Tzimas D, Mckinley M, et al. Endocuff assisted colonoscopy increases adenoma detection rates: a multi-center study. Gastrointest Endosc 2014;79(5 Suppl):AB550
- BACKGROUNDBiecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166. PMID 24921209
- BACKGROUNDHoriuchi A, Nakayama Y, Kato N, Ichise Y, Kajiyama M, Tanaka N. Hood-assisted colonoscopy is more effective in detection of colorectal adenomas than narrow-band imaging. Clin Gastroenterol Hepatol. 2010 Apr;8(4):379-83. doi: 10.1016/j.cgh.2009.08.018. Epub 2009 Aug 26. PMID 19716434
- BACKGROUNDRastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.