Clinical trial · Interventional
Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
NCT02552017CI-TRIAL-00019132ADENOMAunknownN/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)
The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.
Conditions
Conditions (3)
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 | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colonic Polyps | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocuff Vision | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Endocuff Vision-assisted Colonoscopy
- description
- Participants in this arm undergo Endocuff Vision-assisted colonoscopy
- interventionNames
- Device: Endocuff Vision
- type
- NO_INTERVENTION
- label
- Standard Colonoscopy
- description
- Participants in this arm undergo standard colonoscopy
Primary outcomes (1)
- measure
- Adenoma detection rate
- timeFrame
- 10 months
- description
- A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients referred for screening, surveillance, or diagnostic colonoscopy 2. All patients must be able to give informed consent Exclusion Criteria: 1. Patients with any absolute contraindications to colonoscopy 2. Patients with established or suspicion of large bowel obstruction or pseudo-obstruction 3. Patients with known colon cancer or polyposis syndromes 4. Patients with known colonic strictures 5. Patients with known severe diverticular segments (that is likely to impede colonoscope passage) 6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis) 7. Patients lacking capacity to give informed consent 8. Pregnancy 9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure. 10. Patients who are attending for a therapeutic procedure or assessment of a known lesion
References
Publications (1)
- DERIVEDNgu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23. PMID 29363535