N/A
N=427
Use of a Distal Colonoscope Attachment to Increase Detection of Sessile Serrated Adenomas
Sessile Serrated Adenoma
Bottom Line
View on ClinicalTrials.gov: NCT03560037 ↗Enrolled (actual)
427
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Sessile Serrated Adenomas — 42; 59 colonoscopies
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endocuff Vision Assisted Colonoscopy (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sessile Serrated Adenomas |
42; 59 | — |
| SECONDARY Adenoma Detection |
159; 199 | — |
| SECONDARY Proximal Colon Adenomas |
83; 99 | — |
| SECONDARY Adenomas Per Colonoscopy |
0.96; 1.24 | — |
| SECONDARY Sessile Serrated Adenomas Per Colonoscopy |
0.27; 0.35 | — |
| SECONDARY Adenomas Per Positive Colonoscopy |
1.97; 2.12 | — |
| SECONDARY Sessile Serrated Adenomas (SSA) Per Positive Colonoscopy |
1.20; 1.48 | — |
| SECONDARY Colonoscope Withdrawal Time |
14.74; 15.01 | — |
| SECONDARY Differences in Quality of Bowel Preparation |
8.7; 8.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03560037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.