An interventional study of Colonoscopy and Colonoscopy with specific device (Endocuff Vision) in Colorectal Cancer and Adenoma Colon, sponsored by Dr. Alberto Herreros de Tejada Echanojáuregui. Completed at 8 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-22.
Sponsored by Dr. Alberto Herreros de Tejada Echanojáuregui · Not applicable, Interventional, and Diagnostic
Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study
Given the discrepancy in the results of the published studies, the main objective of the present study would be to evaluate, through a multicentric design and with a sufficiently large sample of patients, if there are relevant differences in the ADR and in the MAP between the colonoscopy performed with a device specific (Endocuff visionTM) versus standard colonoscopy.
Secondarily, the number of adenomas, the number of advanced adenomas and the number of serrated lesions in both groups.
All patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria:
Exclusion Criteria:
Patients with a known personal history of hereditary CRC syndrome:
I. No polyposis (Lynch syndrome). II. Polypic.
Colonoscopy with specific device with CE marking (Endocuff Vision)
Device: Colonoscopy with specific device (Endocuff Vision)
Colonoscopy with standard device of the center
Device: Colonoscopy
Patients undergoing screening colonoscopy
Patients undergoing screening colonoscopy using the Endocuff Vision device
Adenoma detection rate (ADR)
Number of adenoma detected by colonoscopy
Time frame: 1 day
Mean adenoma per procedure (MAP)
Mean of adenoma detected by patient
Time frame: 1 day
Total number of adenomas detected by colonoscopy
Time frame: 1 day
Total number of advanced adenomas detected by colonoscopy
Time frame: 1 day
Total number of serrated lesions with or without detected dysplasia by colonoscopy
Time frame: 1 day
Plan to share: Undecided
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Dr. Alberto Herreros de Tejada Echanojáuregui