Ignite Creation Date:
2024-05-06 @ 7:23 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02529007
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2015-07-17
Brief Title:
Endo-cuff Assisted Vs Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening
Sponsor:
Portsmouth Hospitals NHS Trust
Organization:
Portsmouth Hospitals NHS Trust
Study Overview
Official Title:
Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients A Randomised Controlled Trial The E-CAP Study
Status:
COMPLETED
Status Verified Date:
2015-07
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:
E-CAP
Brief Summary:
The study evaluates whether the use of a novel endoscopic cap the endo-cuff at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached
Detailed Description:
Problem statement
In England everyone in the age group of 60-69 years is invited to participate in bowel cancer screening Those who test positive in the initial screening stool test are invited to have a colonoscopy The purpose of colonoscopy is to detect any obvious cancers and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon as polyps have the potential to develop into cancers However colonoscopy still misses up to 25 of polyps Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps There is a need for an improved cap design which will help improve polyp detection
Research questionhypothesis
Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients
Study design
Parallel group single blinded randomised controlled trial
Study participants
Patients attending for colonoscopy under the bowel cancer screening programme
Planned sample size 534
Planned study period 12 months
Primary objective
To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient
In England everyone in the age group of 60-69 years is invited to participate in bowel cancer screening Those who test positive in the initial screening stool test are invited to have a colonoscopy The purpose of colonoscopy is to detect any obvious cancers and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon as polyps have the potential to develop into cancers However colonoscopy still misses up to 25 of polyps Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps There is a need for an improved cap design which will help improve polyp detection
Research questionhypothesis
Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients
Study design
Parallel group single blinded randomised controlled trial
Study participants
Patients attending for colonoscopy under the bowel cancer screening programme
Planned sample size 534
Planned study period 12 months
Primary objective
To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient
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