Ignite Creation Date:
2024-05-06 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03566615
Status:
UNKNOWN
Last Update Posted:
2022-10-06
First Post:
2018-04-30
Brief Title:
Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used
Sponsor:
VA Greater Los Angeles Healthcare System
Organization:
VA Greater Los Angeles Healthcare System
Study Overview
Official Title:
Does the Addition of a Cap Improve the Adenoma Detection Rate During Water Exchange Colonoscopy
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
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:
ASGE
Brief Summary:
This is a study to compare two different but normally used methods of colonoscopy in patients that require a routine or repeat colonoscopy There will be three arms in this study WE water control water plus Cap-1 and water plus Cap-2 The patient will prepare himselfherself for the colonoscopy as per normal instructions and heshe will be given the information for the study at that time so that heshe can make a decision to participate in the study The control method will use water instead of air inserted into the colon The study method will use a new accessory a cap that will fit onto the end of the colonoscope plus water during the procedure This study will also confirm if using the cap method with water is a better way of detecting polyps in the colon and possibly cancer
Detailed Description:
This will be a multi-site multi-national unblinded investigators prospective Random Control Trial RCT Randomization WE WE Cap-1 WE Cap-2 will be based on computer generated random numbers placed inside opaque sealed envelopes The envelope in pre-arranged order will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination This will be a comparison of two different methods with three arms WE WE Cap-1 WE Cap-2 to see which one is better at detecting adenomas
Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure Separate parallel randomization will be set up at each site stratified by investigator and type of colonoscopy screening or surveillance Mode of sedation will include unsedated China US West Los Angeles VA minimally sedated Taiwan on demand sedation Italy Czech Republic US West Los Angeles VA conscious sedation US Sacramento VA and Palo Alto VA or full sedation with propofol Taiwan Randomization prepared by statistics consultant will be carried out by the method of random permuted block design based on computer generated random numbers with variable block sizes of 3 and 6 Gender will be used as a stratification factor
Control Method One arm of the study will include sedatedunsedated colonoscopy with water WE as the control method Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen Infused water will be removed by suction along with residual fecal debris predominantly during insertion
Study method The other two arms entail the addition of a simple commercially available accessory to the colonoscopy device Cap -1 Disposable Distal Attachment or Cap-2 fitted to the colonoscope per manufacturer instruction The two arms include sedatedunsedated colonoscopy with either a Cap-1 plus water or Cap-2 plus water
Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure Separate parallel randomization will be set up at each site stratified by investigator and type of colonoscopy screening or surveillance Mode of sedation will include unsedated China US West Los Angeles VA minimally sedated Taiwan on demand sedation Italy Czech Republic US West Los Angeles VA conscious sedation US Sacramento VA and Palo Alto VA or full sedation with propofol Taiwan Randomization prepared by statistics consultant will be carried out by the method of random permuted block design based on computer generated random numbers with variable block sizes of 3 and 6 Gender will be used as a stratification factor
Control Method One arm of the study will include sedatedunsedated colonoscopy with water WE as the control method Residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen Infused water will be removed by suction along with residual fecal debris predominantly during insertion
Study method The other two arms entail the addition of a simple commercially available accessory to the colonoscopy device Cap -1 Disposable Distal Attachment or Cap-2 fitted to the colonoscope per manufacturer instruction The two arms include sedatedunsedated colonoscopy with either a Cap-1 plus water or Cap-2 plus water
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