Clinical trial · Interventional
Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas
Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas: Multicenter, Prospective and Randomized Study
NCT03436004CI-TRIAL-00040195ENDOCOLEScompletedN/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)
Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study
Conditions
Conditions (2)
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 Colon | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Device | — | UNRESOLVED |
| Colonoscopy with specific device (Endocuff Vision) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Colonoscopy with specific device with CE marking (Endocuff Vision)
- interventionNames
- Device: Colonoscopy with specific device (Endocuff Vision)
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator
- description
- Colonoscopy with standard device of the center
- interventionNames
- Device: Colonoscopy
Primary outcomes (2)
- measure
- Adenoma detection rate (ADR)
- timeFrame
- 1 day
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria: 1. Patients with positive immunologic fecal occult blood test (IFOBT) for population screening. 2. Patients invited to an opportunistic screening colonoscopy or included regional population screening program. 3. Patients with a family history of CRC and indication of screening colonoscopy. 4. Patients with follow-up colonoscopy indication by personal history of adenomas. Exclusion Criteria: 1. Patients with absolute contraindications for colonoscopy (suspicion of intestinal obstruction or perforation, acute diverticulitis suspected or confirmed 6 weeks before the colonoscopy, etc). 2. Symptomatic patients with indication of diagnostic colonoscopy. 3. Patients with a personal history of CRC. 4. Patients with a personal history of chronic inflammatory bowel disease (IBD). 5. Patients with a known personal history of hereditary CRC syndrome: I. No polyposis (Lynch syndrome). II. Polypic. 6. Patients with suspected attenuated polyposis (\> 20 adenomas) with genetic diagnosis not defined. 7. Patients with total or partial colic resection. 8. Complete colonoscopy with an adequate preparation (total Boston ≥6 with at least score ≥2 per segment) in a period of less than a year 9. Pregnant or breastfeeding mothers. 10. Patients who have expressed their wish not to participate or who do not have the ability to understand and / or sign informed consent. 11. Patients with any serious and uncontrolled medical, psychological, psychiatric, geographic or social problem that could interfere with the participation of the patient in the study or not allow an adequate follow-up and adherence with the protocol and evaluation of the results of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.