Clinical trial · Interventional
Effectiveness and Safety of the Colonoscopy Assisted by Endocuff vs. Standard in the Colorectal Cancer Screening
Effectiveness And Safety Of The Colonoscopy Assisted By Endocuff Visio Vs. Standard Colonoscopy In The Colorectal Cancer Screening Program: Clinical Random, Prospective, Multicentric, Open And Parallel Groups
- 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 hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases the detection rate of adenomas thanks to the improved visibility produced by the retraction of the folds and stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF VISION® on the average number of adenomas detected per patient (MAPP) as well as serrated adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety of its use will be estimated.
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 |
|---|---|---|---|
| Cancer Colorectal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy procedure with endocuff | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endocuff
- description
- Colonoscopy procedure with the use of endocuff
- interventionNames
- Device: Colonoscopy procedure with endocuff
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Standard Colonoscopy procedure
- interventionNames
- Device: Colonoscopy procedure with endocuff
Primary outcomes (2)
- measure
- polyps detection rate per patient
- timeFrame
- immediately after the procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: A) Patients between the ages of 50 and 70 referred for a colonoscopy within the colorectal cancer screening program. B) With the ability to provide informed consent Exclusion Criteria: 1. History of inflammatory bowel disease 2. History or suspected obstruction or intestinal pseudo-obstruction located in the colon 3. History of colon cancer or polyposic syndromes 4. History of colonic stenosis 5. History of severe diverticular segments in some region of the colon 6. Subjects unable to provide informed consent 7. Subjects under treatment with clopidogrel, warfarin, acenocoumarol or other new generation anticoagulants that have not discontinued treatment in accordance with the provisions of these procedures 8. Pregnants females 9. Subjects who are going to undergo a therapeutic or surveillance endoscopy for follow-up of injuries diagnosed in previous procedures 10. Subjects whose baseline status does not allow the completion of the questionnaires necessary for the evaluation of the study objectives. 11. History of previous colonic surgery except for appendectomy 12. Any medical, psychological, psychiatric, geographic or social problem that is important and uncontrolled that may interfere with the patient's participation in the study or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.
References
Publications (0)
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