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This study evaluates whether the use of a disposable colonoscope attachment, Endocuff Vision, can increase the detection of sessile serrated adenomas. Participating patients will be randomized to receive either standard colonoscopy or colonoscopy with the Endocuff Vision.
Colon cancer remains the second leading cause of death amongst both men and women in the United States(1). With the advent of screening colonoscopy, mortality from colorectal cancer has decreased, and colonoscopy is the current gold standard for colorectal cancer screening and prevention by removing adenomatous polyps.
Different devices have been employed to assist the endoscopist in the detection of colon adenomas, as these lesions serve as precursors to colon neoplasia. One device of interest is the Endocuff Vision. The Endocuff Vision is a disposable device with a single row of soft, hair-like projections that aid in flattening colonic folds during colonoscope withdrawal to increase the detection of colon adenomas. Previous studies have compared endocuff-assisted colonoscopy to standard colonoscopy, and the results have indicated significant improvement in overall adenoma detection rates (ADR)(2-4). All of these studies have focused on the detection of conventional tubular adenomas as primary endpoints. However, there exists an additional serrated adenoma pathway that may give rise to about 15-20% of colon cancers (5). These lesions tend to be flatter with subtler features that make them harder to detect. A recent meta-analysis suggested that the endocuff was more effective at detecting sessile serrated adenomas compared to standard colonoscopy; however, these findings are derived from secondary data analyses (6). To the best of our knowledge, no study to date has examined the sessile serrated adenoma detection rate as a primary endpoint.
Our previous study examined the differences in overall adenoma detection between endocuff-assisted and standard colonoscopy. Although there was no statistical difference in ADR between endocuff-assisted colonoscopy and standard colonoscopy, investigators did observe a numeric difference in sessile serrated adenoma detection rate (SSADR), 16.7% vs 23.8% (p = 0.5) between standard colonoscopy and endocuff-assisted colonoscopy, respectively. Given the previous sample size was calculated to detect differences in overall ADR, the study was not powered to determine whether this observed difference in SSADR was significant.
Therefore, the goal of the proposed study is to compare standard colonoscopy to endocuff-assisted colonoscopy in patients undergoing colonoscopy for colon cancer screening to determine differences in sessile serrated adenoma detection rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Colonoscopy | No Intervention | Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment. | |
| Endocuff Vision Assisted Colonoscopy | Experimental | Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocuff Vision Assisted Colonoscopy | Device | Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps. |
| Measure | Description | Time Frame |
|---|---|---|
| Sessile Serrated Adenomas | Number of colonoscopies with at least one sessile serrated adenoma | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection | Number of colonoscopies with at least one adenoma | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
| Proximal Colon Adenomas |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28055103 | Background | Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. | |
| 24921209 | Background | Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, Meister T. Novel endocuff-assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled trial. J Clin Gastroenterol. 2015 May-Jun;49(5):413-8. doi: 10.1097/MCG.0000000000000166. |
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All patient de-identified data that is collected during the clinical trial.
Immediately after publication and ending at 5 years after publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Colonoscopy | Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment. |
| FG001 | Endocuff Vision Assisted Colonoscopy | Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment. Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Colonoscopy | Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment. |
| BG001 | Endocuff Vision Assisted Colonoscopy |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sessile Serrated Adenomas | Number of colonoscopies with at least one sessile serrated adenoma | Participants with complete colonoscopy | Posted | Number | colonoscopies | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Colonoscopy | Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher L. Bowlus, MD | University of California Davis | 916-734-8851 | clbowlus@health.ucdavis.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 29, 2018 | Aug 4, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2019 | Aug 4, 2025 | ICF_001.pdf |
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Participants will be enrolled to receive either conventional colonoscopy or colonoscopy with addition of Endocuff Vision device.
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Number of colonoscopies with at least one sessile serrated adenoma or conventional adenoma |
| Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
| Adenomas Per Colonoscopy | Total adenomas detected in each treatment arm divided amongst the number of patients in each arm | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
| Sessile Serrated Adenomas Per Colonoscopy | Total sessile serrated adenomas in each treatment arm divided amongst the number of patients in each arm. | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
| Adenomas Per Positive Colonoscopy | The total adenomas detected divided by the number of colonoscopies with at least one adenoma | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
| Sessile Serrated Adenomas (SSA) Per Positive Colonoscopy | The total sessile serrated adenomas detected divided by the number of colonoscopies with at least one sessile serrated adenoma | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
| Colonoscope Withdrawal Time | The time it takes to withdraw the colonoscope from the cecum to the end of the examination. | Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
| Differences in Quality of Bowel Preparation | Measurement of colon preparation based on the validated Boston Bowel Prep Score. Each colon segment (right, transverse, and left colons) will receive a score of 0 (worse) to 3 (best). The sum of each segment will be reported as a total score of 0 (worse) to 9 (best). | Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
| 28082115 | Background | De Palma GD, Giglio MC, Bruzzese D, Gennarelli N, Maione F, Siciliano S, Manzo B, Cassese G, Luglio G. Cap cuff-assisted colonoscopy versus standard colonoscopy for adenoma detection: a randomized back-to-back study. Gastrointest Endosc. 2018 Jan;87(1):232-240. doi: 10.1016/j.gie.2016.12.027. Epub 2017 Jan 9. |
| 25470133 | Background | Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014. |
| 27546843 | Background | Obuch JC, Ahnen DJ. Colorectal Cancer: Genetics is Changing Everything. Gastroenterol Clin North Am. 2016 Sep;45(3):459-76. doi: 10.1016/j.gtc.2016.04.005. |
| 27920485 | Background | Chin M, Karnes W, Jamal MM, Lee JG, Lee R, Samarasena J, Bechtold ML, Nguyen DL. Use of the Endocuff during routine colonoscopy examination improves adenoma detection: A meta-analysis. World J Gastroenterol. 2016 Nov 21;22(43):9642-9649. doi: 10.3748/wjg.v22.i43.9642. |
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Alcohol consumption | Yes or No | Count of Participants | Participants |
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| Smoking | Never/Former/Current Smoking | Count of Participants | Participants |
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| Secondary | Adenoma Detection | Number of colonoscopies with at least one adenoma | Participants with complete colonoscopy | Posted | Number | colonoscopies | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
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| Secondary | Proximal Colon Adenomas | Number of colonoscopies with at least one sessile serrated adenoma or conventional adenoma | Posted | Number | colonoscopies | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
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| Secondary | Adenomas Per Colonoscopy | Total adenomas detected in each treatment arm divided amongst the number of patients in each arm | Posted | Mean | Standard Deviation | adenomas per participant | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
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| Secondary | Sessile Serrated Adenomas Per Colonoscopy | Total sessile serrated adenomas in each treatment arm divided amongst the number of patients in each arm. | Posted | Mean | Standard Deviation | Sessile Serrated Adenomas Per Participan | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
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| Secondary | Adenomas Per Positive Colonoscopy | The total adenomas detected divided by the number of colonoscopies with at least one adenoma | Posted | Mean | Standard Deviation | Adenomas Per Positive Colonoscopy | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
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| Secondary | Sessile Serrated Adenomas (SSA) Per Positive Colonoscopy | The total sessile serrated adenomas detected divided by the number of colonoscopies with at least one sessile serrated adenoma | Posted | Mean | Standard Deviation | SSA Per Positive Colonoscopy | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
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| Secondary | Colonoscope Withdrawal Time | The time it takes to withdraw the colonoscope from the cecum to the end of the examination. | Posted | Mean | Standard Deviation | minutes | Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
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| Secondary | Differences in Quality of Bowel Preparation | Measurement of colon preparation based on the validated Boston Bowel Prep Score. Each colon segment (right, transverse, and left colons) will receive a score of 0 (worse) to 3 (best). The sum of each segment will be reported as a total score of 0 (worse) to 9 (best). | Posted | Mean | Standard Deviation | score on a scale (0 to 9) | Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion. |
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| EG001 | Endocuff Vision Assisted Colonoscopy | Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment. Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps. | 0 | 211 | 0 | 211 | 0 | 211 |
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