Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used
NCT ID: NCT03566615
Last Updated: 2022-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
1630 participants
INTERVENTIONAL
2018-07-01
2023-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective RCT Of Water Exchange (WE) vs. WE Plus Cap-Assisted Colonoscopy
NCT03160859
Comparison of Polyp Detection and False Alarm Rates in Water Exchange and Air Insufflation Colonoscopy
NCT04727814
Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
NCT02665741
Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates
NCT00577083
Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy
NCT02759081
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 sedated/unsedated 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 sedated/unsedated colonoscopy with either a Cap-1 plus water or Cap-2 plus water.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Water
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.
water
using water instead of traditional air insufflation to help insertion
CAP-straight
A 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-straight
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.
water
using water instead of traditional air insufflation to help insertion
CAP-daisy
A 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.
CAP-daisy
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.
water
using water instead of traditional air insufflation to help insertion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CAP-straight
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.
CAP-daisy
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.
water
using water instead of traditional air insufflation to help insertion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Positive screening for Fecal Immunochemical Test (FIT) or Fecal Occult Blood Test (FOBT).
3. Subjects willing to undergo routine screening and surveillance colonoscopy.
Exclusion Criteria
2. Patients known to have colonic obstruction, inflammatory bowel disease, or active GI bleeding requiring interventions.
3. Patients know to have prior history of severe diverticulitis/diverticulosis.
50 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, Los Angeles
OTHER
VA Greater Los Angeles Healthcare System
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Felix W. Leung
Site PI and Director of Study
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Felix W Leung, MD
Role: PRINCIPAL_INVESTIGATOR
VA Greater Los Angeles Healthcare System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sacramento VAMC, VA Northern California Healthcare System
Mather, California, United States
Veterans Affairs Palo Alto Healthcare System
Palo Alto, California, United States
Xijing Hospital of Digestive Diseases
Xi'an, , China
St. Barbara Hospital
Iglesias, , Italy
Dalin Tzu Chi General Hospital
Chiayi City, , Taiwan
Hualien Tzu Chi Hospital
Hualien City, , Taiwan
Evergreen General Hospital
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Cheng Chiliang, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ASGE 2016 International Award
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.