Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT03436004
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2018-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas
Sponsor:
Dr. Alberto Herreros de Tejada Echanojáuregui
Organization:
Study Overview
Official Title:
Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas: Multicenter, Prospective and Randomized Study
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDOCOLES
Brief Summary:
Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study
Detailed Description:
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.
Secondarily, the number of adenomas, the number of advanced adenomas and the number of serrated lesions in both groups.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: