Clinical trial · Observational
A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®)
A Prospective Randomized Comparison of the Adenoma Detection Rate in Screening Colonoscopy With and Without a Disposable Cap (ENDOCUFF VISION®)
- 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)
The aim of this study is to evaluate the effect of ENDOCUFF VISION® (caps with soft, about 1 cm long lateral feet of rubber ("Endocuff") to flatten the colon folds) on ADR in a real-life setting (general practices) and in a homogenous patient collective (screening colonoscopies only). It is a prospective randomized multi centric study, with participation of at least 10 study sites (private practice). The study is an inverstigator-initiated trial (IIT). Depending on the randomization (closed envelope), the patients are examined with the standard instruments without or with ENDOCUFF VISION®. Group 1: screening colonoscopy with standard colonoscopes with ENDOCUFF VISION® Group 2: screening colonoscopy with standard colonoscopes without cap
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 |
|---|---|---|---|
| Adenoma Detection Rate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocuff group | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group I Endocuff group
- description
- Group I Endocuff cap use
- interventionNames
- Procedure: Endocuff group
- label
- Group II standard colonoscope
- description
- Group II standard colonoscope, no further device used
- interventionNames
- Procedure: Endocuff group
Primary outcomes (1)
- measure
- Adenoma Detection Rate (ADR) in the two study groups
- timeFrame
- through study completion, an average of 1 year
- description
- Differences in ADR with or without the new disposable ENDOCUFF VISION® cap. Hypothesis: Endocuff Vision improves the adenoma detection rate (ADR) by about 25% compared to the comparison group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * \> 55 years * who voluntarily undergo a screening colonoscopy * information and signed declaration of consent Exclusion Criteria: * symptoms that may indicate a colonic disease * rectal/colonic bleeding * known colon disease for further diagnosis, e.g. Carcinoma, polyps for erosion, inflammatory bowel disease, stenosis * follow-up/surveillance after colon carcinoma surgery or polypectomy * anticoagulant drugs that make a biopsy or polypectomy impossible * poor general condition (from ASA (American Society of Anesthesiologists Classification) III) * partial/incomplete colonoscopy planned
References
Publications (21)
- 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
- BACKGROUNDCorley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086. PMID 24693890
- BACKGROUNDBretagne JF, Ponchon T. Do we need to embrace adenoma detection rate as the main quality control parameter during colonoscopy? Endoscopy. 2008 Jun;40(6):523-8. doi: 10.1055/s-2007-995786. Epub 2008 May 8. No abstract available. PMID 18464196
- BACKGROUNDvan Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x. PMID 16454841
- BACKGROUNDBrenner H, Altenhofen L, Kretschmann J, Rosch T, Pox C, Stock C, Hoffmeister M. Trends in Adenoma Detection Rates During the First 10 Years of the German Screening Colonoscopy Program. Gastroenterology. 2015 Aug;149(2):356-66.e1. doi: 10.1053/j.gastro.2015.04.012. Epub 2015 Apr 22. PMID 25911510
- BACKGROUNDMoriyama T, Uraoka T, Esaki M, Matsumoto T. Advanced technology for the improvement of adenoma and polyp detection during colonoscopy. Dig Endosc. 2015 Apr;27 Suppl 1:40-4. doi: 10.1111/den.12428. PMID 25556542
- BACKGROUNDOmata F, Ohde S, Deshpande GA, Kobayashi D, Masuda K, Fukui T. Image-enhanced, chromo, and cap-assisted colonoscopy for improving adenoma/neoplasia detection rate: a systematic review and meta-analysis. Scand J Gastroenterol. 2014 Feb;49(2):222-37. doi: 10.3109/00365521.2013.863964. Epub 2013 Dec 16.