Ignite Creation Date:
2024-05-06 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03442738
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2018-02-02
Brief Title:
A Prospective Randomized Comparison of the Adenoma Detection Rate With a Disposable Cap ENDOCUFF VISION
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
A Prospective Randomized Comparison of the Adenoma Detection Rate in Screening Colonoscopy With and Without a Disposable Cap ENDOCUFF VISION
Status:
COMPLETED
Status Verified Date:
2023-06
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:
Endocuff
Brief Summary:
The aim of this study is to evaluate the effect of ENDOCUFF VISION caps with soft about 1 cm long lateral feet of rubber Endocuff to flatten the colon folds on ADR in a real-life setting general practices and in a homogenous patient collective screening colonoscopies only
It is a prospective randomized multi centric study with participation of at least 10 study sites private practice The study is an inverstigator-initiated trial IIT
Depending on the randomization closed envelope the patients are examined with the standard instruments without or with ENDOCUFF VISION
Group 1 screening colonoscopy with standard colonoscopes with ENDOCUFF VISION Group 2 screening colonoscopy with standard colonoscopes without cap
It is a prospective randomized multi centric study with participation of at least 10 study sites private practice The study is an inverstigator-initiated trial IIT
Depending on the randomization closed envelope the patients are examined with the standard instruments without or with ENDOCUFF VISION
Group 1 screening colonoscopy with standard colonoscopes with ENDOCUFF VISION Group 2 screening colonoscopy with standard colonoscopes without cap
Detailed Description:
Colonoscopy is currently the best method for the detection of colon carcinomas and as precursor adenomas since these can also be biopsied and removed Therefore the screening colonoscopy was introduced at the end of 2002 covered by state insurance from the age of 55 The main quality parameter for outcome quality is the adenoma detection rate ADR which correlates with the rate of the carcinomas prevented However since even smaller polyps especially if they are flat or sunken may be relevant for colon cancer development the aim of colonoscopy should be to be able to recognize and remove as many adenomas as possible There is a need to optimize the efficiency of screening colonoscopy by increasing the rate of adenoma detection as it is known from many studies that approximately 15-30 of adenomas can be missed- even though the adenoma rate in the German screening colonoscopy register continues to increase over the years and currently stands at 28
Previous studies on the increase of the adenoma detection rate by endoscopy concerning newer endoscope technologies including conventional caps have been almost entirely negative
For about 2 years a newer version of ENDOCUFF VISION caps caps with soft about 1 cm long lateral feet of rubber Endocuff to flatten the colon folds is available which has already been used in about 8000 colonoscopies in Germany and another 10000 colonoscopies in Europe there are no studies on this version of Endocuff caps
The aim of this study is to evaluate the effect of ENDOCUFF VISION in a real-life setting general practices and in a homogenous patient collective screening colonoscopies only
It is a prospective randomized multi centric study with participation of at least 10 study sites private practice The study is an inverstigator-initiated trial IIT
A new technique for ADR improvement within colonoscopy can only be tested in a comparative study in two groups comparing the adenoma rate between the two groups An independent gold standard does not exist in this sense but the confirmation by the endoscopically taken histology serves as gold standard for the diagnosis adenoma The alternative of double examinations tandem colonoscopy in each patient is in the setting of private practice not feasible
Depending on the randomization closed envelope the patients are examined with the standard instruments without or with ENDOCUFF VISION
Group 1 screening colonoscopy with standard colonoscopes with ENDOCUFF VISION Group 2 screening colonoscopy with standard colonoscopes without cap
Previous studies on the increase of the adenoma detection rate by endoscopy concerning newer endoscope technologies including conventional caps have been almost entirely negative
For about 2 years a newer version of ENDOCUFF VISION caps caps with soft about 1 cm long lateral feet of rubber Endocuff to flatten the colon folds is available which has already been used in about 8000 colonoscopies in Germany and another 10000 colonoscopies in Europe there are no studies on this version of Endocuff caps
The aim of this study is to evaluate the effect of ENDOCUFF VISION in a real-life setting general practices and in a homogenous patient collective screening colonoscopies only
It is a prospective randomized multi centric study with participation of at least 10 study sites private practice The study is an inverstigator-initiated trial IIT
A new technique for ADR improvement within colonoscopy can only be tested in a comparative study in two groups comparing the adenoma rate between the two groups An independent gold standard does not exist in this sense but the confirmation by the endoscopically taken histology serves as gold standard for the diagnosis adenoma The alternative of double examinations tandem colonoscopy in each patient is in the setting of private practice not feasible
Depending on the randomization closed envelope the patients are examined with the standard instruments without or with ENDOCUFF VISION
Group 1 screening colonoscopy with standard colonoscopes with ENDOCUFF VISION Group 2 screening colonoscopy with standard colonoscopes without cap
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