Ignite Creation Date:
2024-05-06 @ 10:14 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03197987
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2017-06-22
Brief Title:
Comparison of Two Devices During Colonoscopy
Sponsor:
Hospital General Universitario Elche
Organization:
Hospital General Universitario Elche
Study Overview
Official Title:
Endocuff vs Transparent Cap To Increase Adenoma Detection Rate During Colonoscopy
Status:
COMPLETED
Status Verified Date:
2018-11
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:
COLONAUX
Brief Summary:
Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening Adenoma detection rate is a marker of high quality colonoscopy In this study we compare two devices Endocuff TM and cap that can increase the adenoma detection rate during colonoscopy
Detailed Description:
Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers Several technological advancements have been explored to improve adenoma detection rate Endocuff Vision has been shown to improve adenoma detection rate in several studies Cap-assisted colonoscopy is a technique that allow improved visualization of the colonic folds by flattening the fold within the viewing field However studies have reported mixed results on adenoma detection in cap-assisted colonoscopy
This is a prospective single-centre randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision-assisted colonoscopy versus cap-assisted colonoscopy Patients are randomized according to bowel cancer screening status to receive Endocuff Vision-assisted colonoscopy or cap colonoscopy on the day of procedure Baseline data colonoscopy and polyp data including histology are collected Patients are followed up at 30 days for complications This study will take place in an University Hospital in Spain A maximum of 9 expert colonoscopists will recruit a total of 712 patients
This is the first trial to evaluate the adenoma detection rate of Endocuff Vision vs cap colonoscopy in all screening surveillance and diagnostic patient groups This study will guide clinicians to decide what device to use to increase adenoma detection rate in routine colonoscopy
This is a prospective single-centre randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision-assisted colonoscopy versus cap-assisted colonoscopy Patients are randomized according to bowel cancer screening status to receive Endocuff Vision-assisted colonoscopy or cap colonoscopy on the day of procedure Baseline data colonoscopy and polyp data including histology are collected Patients are followed up at 30 days for complications This study will take place in an University Hospital in Spain A maximum of 9 expert colonoscopists will recruit a total of 712 patients
This is the first trial to evaluate the adenoma detection rate of Endocuff Vision vs cap colonoscopy in all screening surveillance and diagnostic patient groups This study will guide clinicians to decide what device to use to increase adenoma detection rate in routine colonoscopy
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None