Ignite Creation Date:
2024-05-06 @ 3:37 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02331836
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2015-01-02
Brief Title:
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy
Sponsor:
Helios Albert-Schweitzer-Klinik Northeim
Organization:
Helios Albert-Schweitzer-Klinik Northeim
Study Overview
Official Title:
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection A Randomized Controlled European Multicenter Study
Status:
COMPLETED
Status Verified Date:
2019-02
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:
EC-Cap-SC
Brief Summary:
Comparison of Endocuff-assisted Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate ADR
Detailed Description:
The Endocuff is a medical device approved in 2012 by the American Food and Drug Administration which was also authorized by the European Agency for the Evaluation of Medicinal Products The aim of the cuff is to optimize the view of the colonic mucosa There is also a transparent cap on the market which is used in colonoscopy for a better evaluation of the mucosa and polyp detection The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None