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Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used (ASGE)

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ClinicalTrials.gov Identifier: NCT03566615
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Felix W. Leung, VA Greater Los Angeles Healthcare System

Tracking Information
First Submitted Date  ICMJE April 30, 2018
First Posted Date  ICMJE June 25, 2018
Last Update Posted Date October 11, 2018
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
Adenoma detection rate [ Time Frame: 2 years ]
The proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas, or polyps, detected.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03566615 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
  • Cecal intubation [ Time Frame: 2 hours: Data collected during colonoscopy procedure ]
    Visualization of ileocecal valve/appendix orifice and the medial wall of the cecum with colonoscope tip touching floor of cecum
  • Boston bowel preparation score [ Time Frame: 2 hours: Data collected during colonoscopy procedure ]
    Three segments (Right, transverse, left colon), each with 0 to 3 (poor to excellent); total scores = sum (10 point scale)
  • Cecal intubation time [ Time Frame: 2 hours: Data collected during colonoscopy procedure ]
    Total time from insertion into the anus to arrival in the cecum
  • Visual analogue scale (0=not satisfied, 10=very satisfied) [ Time Frame: 2 hours: Data collected during colonoscopy procedure ]
    Patient satisfaction
  • Willing to repeat [ Time Frame: 2 hours: Data collected during colonoscopy procedure ]
    Visual analogue scale (0=not willing, 10=willing)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does the Cap Increase the Finding of Polyps When Water Exchange Colonoscopy is Used
Official Title  ICMJE Does the Addition of a Cap Improve the Adenoma Detection Rate During Water Exchange Colonoscopy
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.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE
  • Colonoscopy
  • Polyp of Colon
Intervention  ICMJE
  • Device: 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.
  • Device: 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.
  • Other: water
    using water instead of traditional air insufflation to help insertion
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Other: water
  • Experimental: 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.
    Interventions:
    • Device: CAP-straight
    • Other: water
  • Experimental: 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.
    Interventions:
    • Device: CAP-daisy
    • Other: water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2018)
1630
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female 50-75 yrs of age.
  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:

  1. Patients who decline to provide informed consent.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nora Jamgotchian, MS 818-895-9426 Nora.Jamgotchian@va.gov
Contact: Felix W Leung, MD 818-891-7711 ext 32520 Felix.Leung@va.gov
Listed Location Countries  ICMJE China,   Italy,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03566615
Other Study ID Numbers  ICMJE ASGE 2016 International Award
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Felix W. Leung, VA Greater Los Angeles Healthcare System
Study Sponsor  ICMJE VA Greater Los Angeles Healthcare System
Collaborators  ICMJE University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Felix W Leung, MD VA Greater Los Angeles Healthcare System
PRS Account VA Greater Los Angeles Healthcare System
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP