Sessile Serrated AdenomaNCT03560037
Use of a Distal Colonoscope Attachment to Increase Detection of Sessile Serrated Adenomas
A study testing Endocuff Vision Assisted Colonoscopy in people with Sessile Serrated Adenoma, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sessile Serrated Adenoma
- What is being tested?
- Endocuff Vision Assisted Colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 427 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 5 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients who present to our outpatient gastroenterology suites for screening colonoscopy.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Medical Center
Sacramento, California, 95817
About this study
Official title: 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.
Read the 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.
- Conditions
- Sessile Serrated Adenoma
- Being tested
- Endocuff Vision Assisted Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocuff Vision Assisted ColonoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Endocuff Vision Assisted Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sessile Serrated Adenomas
Number of colonoscopies with at least one sessile serrated adenoma
Measured: 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
Number of colonoscopies with at least one adenoma
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 May 2019
- Primary completion5 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sessile Serrated AdenomaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled to receive either conventional colonoscopy or colonoscopy with addition of Endocuff Vision device.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560037
- Sponsor's protocol ID
- 1164295
- Status last verified
- Sep 2025
- First submitted
- 10 Apr 2018
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All patient de-identified data that is collected during the clinical trial.
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.
PubMed 28055103Biecker 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.
PubMed 24921209De 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.
PubMed 28082115Floer 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.
PubMed 25470133Obuch 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.
PubMed 27546843Chin 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.
PubMed 27920485
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Endocuff Vision to Increase Detection of Sessile Serrated Adenomas During Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT03560037
- Acronym / sponsor ID
- 1164295
- Conditions
- Sessile Serrated Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be enrolled to receive either conventional colonoscopy or colonoscopy with addition of Endocuff Vision device.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Endocuff Vision Assisted ColonoscopyPatients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who present to our outpatient gastroenterology suites for screening colonoscopy.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocuff Vision Assisted ColonoscopyDetachable 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. | Device | Endocuff Vision Assisted Colonoscopy |
Primary outcome
Sessile Serrated Adenomas
Time frame: 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.
Number of colonoscopies with at least one sessile serrated adenoma
8 secondary outcomes
Adenoma Detection
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28055103Siegel 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.
- Background: PubMed 24921209Biecker 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.
- Background: PubMed 28082115De 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.
- Background: PubMed 25470133Floer 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.
- Background: PubMed 27546843Obuch 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.
- Background: PubMed 27920485Chin 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.
- Individual participant dataSharing planned: Yes. All patient de-identified data that is collected during the clinical trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocuff Vision Assisted Colonoscopy in people with Sessile Serrated Adenoma, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sessile Serrated Adenomas (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03560037, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.