Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas
Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone
Design: Multicenter, Prospective, randomized controlled study
Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Condition or disease | Intervention/treatment | Phase |
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Colorectal Adenoma | Procedure: Colonoscopy Device: distal Cap Device: Endocuff | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1227 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Three Arm Randomized Control Trial |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Randomization will be done by computer allocation |
Primary Purpose: | Diagnostic |
Official Title: | Three Arm Prospective Randomized Controlled Trial of HD White-light Colonoscopy vs HD White-light Colonoscopy With Reveal® Distal Attachment Cap Versus HD White-light Colonoscopy With Endocuff Vision for the Detection of Colorectal Adenomas |
Actual Study Start Date : | March 16, 2018 |
Estimated Primary Completion Date : | January 20, 2020 |
Estimated Study Completion Date : | June 10, 2020 |
Arm | Intervention/treatment |
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Active Comparator: High-Definition White-light Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps
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Procedure: Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps
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Active Comparator: High-Definition White-light Colonoscopy With Reveal®
Using an instrument called cap at end of colonoscope which is used to straighten colon folds
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Procedure: Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps
Device: distal Cap Using an instrument called cap at end of colonoscope which is used to straighten colon folds
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Active Comparator: High-Definition White-light Colonoscopy With Endocuff Vision
Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
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Procedure: Colonoscopy
Using an instrument called colonoscope which is used to detect colonic polyps
Device: Endocuff Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
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Ages Eligible for Study: | 18 Years to 110 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Prateek Sharma, MD | (816) 861-4700 ext 56735 | prateek.sharma@va.gov |
United States, Missouri | |
Kansas City VA Hospital | Recruiting |
Kansas City, Missouri, United States, 64128 | |
Contact: April Higbee, RN, BSN 816-861-4700 ext 57456 april.higbee@va.gov | |
Contact: Chandra Dasari, MD 816-861-4700 ext 55304 | |
Principal Investigator: Prateek Sharma, MD |
Principal Investigator: | Prateek Sharma, MD | Kansas City VA Hospital |
Tracking Information | |||||||
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First Submitted Date ICMJE | October 23, 2017 | ||||||
First Posted Date ICMJE | May 16, 2019 | ||||||
Last Update Posted Date | November 22, 2019 | ||||||
Actual Study Start Date ICMJE | March 16, 2018 | ||||||
Estimated Primary Completion Date | January 20, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Adenoma detection rate [ Time Frame: Through the study (1 year) ] To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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 | Three Arm Rand Trial of HD Light vs Reveal® Cap vs Endocuff Cap for Detection of Colorectal Adenomas (TRACE) | ||||||
Official Title ICMJE | Three Arm Prospective Randomized Controlled Trial of HD White-light Colonoscopy vs HD White-light Colonoscopy With Reveal® Distal Attachment Cap Versus HD White-light Colonoscopy With Endocuff Vision for the Detection of Colorectal Adenomas | ||||||
Brief Summary |
Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal® Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone Design: Multicenter, Prospective, randomized controlled study Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. |
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Detailed Description |
Hypothesis and specific aims of the Study We hypothesize that the detection rate of patients with colorectal adenomas will be higher with HDWL colonoscopy with Reveal® distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopy alone. Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal® distal attachment cap versus HDWL colonoscopy with Endocuff Vision. Secondary Aims:
Methodology: This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. They will be randomized to one of 3 arms, i.e. HDWL colonoscopy HDWL colonoscopy with Reveal® cap or HDWL colonoscopy with Endocuff Vision. Enrollment: A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study. Length of the study: The duration of the study is expected to be approximately 12 months. Enrollment of study patients will cease when approximately 1227 patients have been enrolled. Inclusion criteria
Exclusion criteria
For three groups, moderate sedation will be administered in a standard fashion with intravenous midazolam, meperidine or fentanyl prior to undergoing colonoscopy. The colonoscope (HDWL colonoscope or HDWL colonoscope with Reveal® cap or HDWL colonoscope with Endocuff Vision) will be inserted and cecum will be intubated. Photo documentation of the cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope. The time from the point of insertion of the colonoscope into the rectum to the intubation of cecum will be recorded with a stop watch by a research coordinator and will be documented as the "insertion time". The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the "withdrawal time". During withdrawal of the colonoscope the stop watch will be stopped whenever mucosa is being cleaned, fluid/solid debris is suctioned or a polyp is being removed to ensure that the withdrawal time is the actual representation of the mucosal inspection time. Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds, flexures and valves. All polyps detected will be documented: size, location, and morphology (using the Paris classification - Appendix A). Photo documentation of the polyps will be performed. Polyps will then be removed with a biopsy forceps or snare and sent for histopathological evaluation, each in a separate jar and labeled accordingly. The bowel preparation will be evaluated and graded according to previously reported criteria using the Boston Bowel Preparation Scale (Appendix B). Complications including any mucosal trauma from the high definition colonoscope alone or with high definition colonoscope with Reveal® cap or Endocuff Vision, perforation or gastrointestinal bleeding (requiring intervention) will be recorded for three groups. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Three Arm Randomized Control Trial Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Randomization will be done by computer allocation Primary Purpose: Diagnostic
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Condition ICMJE | Colorectal Adenoma | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
1227 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | June 10, 2020 | ||||||
Estimated Primary Completion Date | January 20, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 110 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03952611 | ||||||
Other Study ID Numbers ICMJE | RND#00978 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Midwest Veterans' Biomedical Research Foundation ( Midwest Biomedical Research Foundation ) | ||||||
Study Sponsor ICMJE | Midwest Biomedical Research Foundation | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Midwest Veterans' Biomedical Research Foundation | ||||||
Verification Date | November 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |