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

NCT03560037 | Completed Results FDA Device

• 1 other identifier: 1164295
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sessile Serrated Adenoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Adenoma Detection

  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

  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

  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

  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

  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.

Study Arms (2)

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.

Device: Endocuff Vision Assisted Colonoscopy

Interventions

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.

Endocuff Vision Assisted Colonoscopy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (6)

• 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.

  PMID: 28055103 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.

  PMID: 24921209 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.

  PMID: 28082115 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.

  PMID: 25470133 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.

  PMID: 27546843 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.

  PMID: 27920485 BACKGROUND

Results Point of Contact

• Title: Christopher L. Bowlus, MD
• Organization: University of California Davis

clbowlus@health.ucdavis.edu

916-734-8851

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be enrolled to receive either conventional colonoscopy or colonoscopy with addition of Endocuff Vision device.

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: June 18, 2018
• Study Start: May 1, 2019
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately after publication and ending at 5 years after publication.

Locations

US (1)