Clinical trial · Interventional
Serrated Lesions Detection With Endocuff-assisted Colonoscopy
Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial
- 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)
Colorectal cancer (CRC) is a leading cause of morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.
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 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Serrated Lesion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| control | Device | — | UNRESOLVED |
| Endocuff colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endocuff colonoscopy
- description
- Colonoscopy performed with Endocuff
- interventionNames
- Device: Endocuff colonoscopy
- type
- PLACEBO_COMPARATOR
- label
- Conventional colonoscopy
- description
- Colonoscopy performed without any device
- interventionNames
- Device: control
Primary outcomes (1)
- measure
- Average number of serrated lesions ≥ 10 mm detected per colonoscopy
- timeFrame
- immediate
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: \- Outpatients undergoing elective colonoscopies Exclusion Criteria: * Known polyposis syndromes * Personal colorectal cancer history * Previous colorectal surgery * Severe diverticulosis * Colonic stricture * Inflammatory bowel disease * Primary sclerosing cholangitis * Pregnancy and breastfeeding
References
Publications (0)
Data not yet available