Use of a Distal Colonoscope Attachment to Increase Detection of Sessile Serrated Adenomas

Use of Endocuff Vision to Increase Detection of Sessile Serrated Adenomas During Screening Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: Sessile Serrated Adenoma
• Intervention / Treatment: Device: Endocuff Vision Assisted Colonoscopy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 427
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients who present to our outpatient gastroenterology suites for screening colonoscopy.

Exclusion Criteria:

• Age less than 45 and greater than 85
• Prior history of colon polyps (hyperplastic polyp, tubular adenoma or sessile serrated adenoma) and colon cancer
• Patients with inflammatory bowel disease
• Patients suspected to have colon cancer based on non-invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema).
• Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc., or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon
• Patients with family history of colon cancer in 1st degree relative below the age of 60
• Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc., which are associated with an increased risk of colon cancer
• Patients unable to consent
• Pregnant patients
• Incarcerated patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Colonoscopy; Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
Experimental: Endocuff Vision Assisted Colonoscopy; Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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	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.

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 1164295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All patient de-identified data that is collected during the clinical trial.
• IPD Sharing Time Frame: Immediately after publication and ending at 5 years after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes