Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used
ASGE
Does the Addition of a Cap Improve the Adenoma Detection Rate During Water Exchange Colonoscopy
1 other identifier
interventional
1,630
4 countries
7
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 himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
June 25, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedOctober 6, 2022
October 1, 2022
4.5 years
April 30, 2018
October 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adenoma detection rate
The proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas, or polyps, detected.
2 years
Secondary Outcomes (5)
Cecal intubation
2 hours: Data collected during colonoscopy procedure
Boston bowel preparation score
2 hours: Data collected during colonoscopy procedure
Cecal intubation time
2 hours: Data collected during colonoscopy procedure
Visual analogue scale (0=not satisfied, 10=very satisfied)
2 hours: Data collected during colonoscopy procedure
Willing to repeat
2 hours: Data collected during colonoscopy procedure
Study Arms (3)
Water
ACTIVE COMPARATORResidual air in the colon will be removed, 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.
CAP-straight
EXPERIMENTALA straight transparent cap was fitted to the colonoscope per manufacturer instruction.Residual air in the colon will be removed, 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.
CAP-daisy
EXPERIMENTALA daisy cap transparent cap was fitted to the colonoscope per manufacturer instruction.Residual air in the colon will be removed, 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. Note: IRB Approval date for the use of Endocuff at St. Barbara Hospital, Iglesias (CA), Italy, was obtained on 3/8/2017. IRB Approval date for the use of Endocuff at Evergreen General Hospital, Taipei, Taiwan, was obtained on 3/18/2021.
Interventions
This study is to detect any differences in the detection rate of adenomas using straight caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.
This study is to detect any differences in the detection rate of adenomas using daisy caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.
using water instead of traditional air insufflation to help insertion
Eligibility Criteria
You may qualify if:
- Male and female 50-75 yrs of age.
- Positive screening for Fecal Immunochemical Test (FIT) or Fecal Occult Blood Test (FOBT).
- Subjects willing to undergo routine screening and surveillance colonoscopy.
You may not qualify if:
- Patients who decline to provide informed consent.
- Patients known to have colonic obstruction, inflammatory bowel disease, or active GI bleeding requiring interventions.
- Patients know to have prior history of severe diverticulitis/diverticulosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Sacramento VAMC, VA Northern California Healthcare System
Mather, California, 95655-4200, United States
Veterans Affairs Palo Alto Healthcare System
Palo Alto, California, 94550, United States
Xijing Hospital of Digestive Diseases
Xi'an, 710032, China
St. Barbara Hospital
Iglesias, Italy
Dalin Tzu Chi General Hospital
Chiayi City, 622, Taiwan
Hualien Tzu Chi Hospital
Hualien City, Taiwan
Evergreen General Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felix W Leung, MD
VA Greater Los Angeles Healthcare System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Site PI and Director of Study
Study Record Dates
First Submitted
April 30, 2018
First Posted
June 25, 2018
Study Start
July 1, 2018
Primary Completion
December 31, 2022
Study Completion
January 31, 2023
Last Updated
October 6, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share