Use of Endocuff Vision to Increase Detection of Sessile Serrated Adenomas During Screening Colonoscopy
Phase: NA
Conditions: Sessile Serrated Adenoma
Sponsor: University of California, Davis

PROTOCOL TITLE: Use of a Distal Colonoscope Attachment to Increase Detection of 
Sessile Serrated Adenomas 
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1) 
Protocol Title 
Title:  Use of a Distal Colonoscope Attachment to Increase Detection 
of Sessile Serrated Adenomas  
Protocol Version Date: October 29, 2018 
2) 
Objectives 
We plan to compare standard colonoscopy to endocuff-assisted 
colonoscopy. 
Primary Endpoint: Differences in sessile serrated adenoma detection rate 
(SSADR) 
 
Secondary Endpoints: Differences in: 
1. Adenoma Detection Rate 
2. Proximal Colon Adenoma Detection Rate  
3) 
Background 
 
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 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.7 Although there was no statistical 
difference in ADR between endocuff-assisted colonoscopy and standard 
colonoscopy, we 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 our previous sample size 

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was calculated to detect differences in overall ADR, we were not powered to 
determine whether this observed difference in SSADR was significant.  
 
Therefore, the goal of our 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.   
 
References: 
 
1 
Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017;67(1):7-30. 
2 
Biecker E, Floer M, Heinecke A, Strobel P, Bohme R, Schepke M, et al. Novel endocuff-
assisted colonoscopy significantly increases the polyp detection rate: a randomized controlled 
trial. J Clin Gastroenterol. 2015;49(5):413-8. 
3 
De Palma GD, Giglio MC, Bruzzese D, Gennarelli N, Maione F, Siciliano S, et al. Cap cuff-
assisted colonoscopy versus standard colonoscopy for adenoma detection: a randomized back-
to-back study. Gastrointest Endosc. 2017. 
4 
Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, et al. Higher adenoma 
detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter 
trial. PLoS One. 2014;9(12):e114267. 
5 
Obuch JC, Ahnen DJ. Colorectal Cancer: Genetics is Changing Everything. Gastroenterol 
Clin North Am 2016;45:459-76. 
6 
Chin M, Karnes W, Jamal MM, Lee JG, Lee R, Samarasena J, et al. Use of the Endocuff 
during routine colonoscopy examination improves adenoma detection: A meta-analysis. 
World J Gastroenterol. 2016;22(43):9642-9. 

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7 
Marsano J, Johnson S, Yan, S, et al. Comparison of Colon Adenoma Detection Rate Using 2 
Distal Colonoscope Attachments: A Single Center RCT. Am J Gastroenterol. 2017; S113-
114.  
 
 
4) 
Inclusion and Exclusion Criteria 
 
         Inclusion criteria:  
 
(1) Patients between ages of 40 and 85 who are scheduled for screening 
colonoscopy with the following gastroenterologists at UC Davis :  
Dr. Joseph Marsano  
Dr. Sooraj Tejaswi 
Dr. Asha Gupta 
Dr. Amar Al-Juburi 
Dr. Jesse Stondell  
Dr. Juan Carlos Garcia 
Dr. Eric Mao 
 
Exclusion criteria: 
 
The following patients will be excluded: 
 
(1) Age less than 40 and greater than 85 
(2) Prior history of colon adenomas (tubular adenoma,sessile serrated 
adenoma, tubulovillous or villous adenomas) and colon cancer 
 
(3) Patients with inflammatory bowel disease 
(4) 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).  
(5) 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 
(6) 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 
 
(7) Patients unable to consent  
 
(8) Pregnant patients 
 
(9) Incarcerated patients  
                  (10) Non-English speaking patients  
 
 
Number of Subjects: 
We plan on recruiting a total of 1374 subjects with 687 subjects randomized to     
each arm.  
 
 

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          Consent Process 
Currently, the standard practice is to obtain informed consent prior to a 
colonoscopy. Some of the patients presenting for their colonoscopy are via open 
access, thus no colonoscopy specific clinic appointments are done before their 
actual procedure.  
 
Patients that are identified as being eligible for the study will be contacted 3 
weeks prior to their procedure (if possible) but no less than one week. They will 
be contacted by IRB- approved secured Mychart message via the electronic 
medical record or telephone by research personnel via IRB approved phone script 
to inform them of the study. Information regarding the procedure and goal of the 
study will be provided to allow for sufficient time prior to their procedure to 
consider participation. A copy of the consent form will also be sent to them via 
mychart or mail. 
 
Patients agreeing to participate in the study will sign the informed consent form 
on the day of the scheduled colonoscopy procedure. Patients will be able to ask 
the consenting physician any questions regarding the study prior to signing the 
consent form. 
 
As part of routine practice, our endoscopists will discuss with the patients about 
the colonoscopy - including consent, medication/ history review and discussions 
about the risks/benefits of the procedure. This conversation typically occurs in a 
quiet and private section in the pre-op rooms about 30-60 minutes before the 
procedure. The written consent discussion specific to our study will also be done 
in this same area. There is usually adequate time prior to the procedure for both 
the consents to be done.  
 
Please see attached Consent form (HRP-502).  Non-English speakers will not be 
included in the study due to the practical difficulty with translating the study 
materials and consents. Patients that are unable to provide consent for themselves 
will not be included in the study.  
 
            HIPAA Authorization for Research 
            With the approval of HIPAA Waiver of Authorization (HRP-441), the study 
coordinator may identify potential subjects through the Electronic Medical Record 
(EMR). Following the identification of a patient as a potential subject, the study 
coordinator may inform the potential subjects of the study via secured communication 
(MyChart messages) or telephone with an IRB-approved phone script.   
5) 
Study Timelines 
 
Timeline for enrollment of subjects will be November 2018 – May 2020. Data will be 
obtained from all patient medical records on an ongoing basis and completed once their 
pathology report is finalized (sessile serrated adenoma vs tubular adenoma vs. non-
adenomatous polyps). Primary data analysis will begin immediately once all patients 

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have been enrolled, completed colonoscopy and all data collected. We anticipate that 
primary data analysis will be completed by June 2020. This will be a one-time 
participation during the date of their procedure only. Subjects will only be contacted by 
their endoscopist for communication of colonoscopy results per regular standard practice 
at UC Davis. 
 
6) 
Study Endpoints 
 
Primary Endpoint: 
- 
Sessile Serrated Adenoma Detection Rate  
 
Secondary Endpoints: 
- 
Overall adenoma detection rate 
- 
Proximal colon adenoma detection rate  
- 
Mean number of adenomas per colonoscopy  
- 
Mean number of sessile serrated adenomas per colonoscopy  
- 
Adenomas per positive colonoscopy  
- 
Sessile serrated adenomas per positive colonoscopy  
- 
Colonoscope withdrawal time  
- 
Differences if quality of colon preparation  
- 
Major complication rates (perforation, major bleeding causing transfusion) 
 
7) 
Procedures Involved 
 
Our proposed study is a randomized control trial in which patients are randomized in a 
single-blinded fashion into one of 2 study arms. One arm of subjects will undergo their 
screening colonoscopy without any colonoscope attachments (conventional). A second 
arm of subjects will undergo their screening colonoscopy with the Endocuff Vision 
attachment. 
 
All methods (colonoscopy without any attachment and colonoscopy with Endocuff 
Vision attachment) are approved standard of care options, and are already in clinical use.  
 
Data that will be reviewed as part of the study includes: age, gender, smoking status, 
alcohol consumption, body mass index (BMI), history of diabetes, quality of bowel prep, 
withdrawal time, the number of polyps, location of polyps removed, size of the polyps 
removed, and histopathology of the polyps. These are data points that are routinely 
collected and reported as part of regular care of patients. This data will be reviewed and 
entered into the REDCap database by medical students, residents or fellows. GI faculty 
members’ role will be to obtain consent, perform procedures, and analysis of the de-
identified data.    
 

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8) 
Data and/or Specimen Management and Confidentiality 
 
Data will be accessed from patient records using an encrypted, password-protected 
computer at UC Davis Medical Center.  The computer is stored in the GI office in PSSB 
building. This room is accessible by staff/faculty members of the UC Davis 
Gastroenterology department. Each study patient will be assigned a unique study number. 
Patient identifier, including patient name (First and Last) and  medical record number 
(MRN)associated with the study number will be entered into password protected 
REDCap along with other aforementioned data The principal investigators will not have 
access to the REDCap database, and research staff responsible for data entry will export 
de-identified data and distribute de-identified  data to the investigators conducting data 
analysis.   
As staff of UC Davis, each investigator will have completed  HIPAA compliance 
training.   
 
The data collected will be analyzed using a one-way ANOVA. Using a baseline incidence 
of sessile serrated adenoma detection rate of 10%, and to detect an effect size of 50%, 
with a power of 0.809, we would need 687 subjects in each study arm. We therefore 
aimed to enroll 687 subjects into each arm (2 arms for a total of 1374 subjects) to ensure 
we have enough subjects in each arm to detect an effect if present.  
 
9) 
Data and/or Specimen Banking 
 
Linkage between patient identifiers(First Name, Last Name, and MRN) and study 
number including other data will be saved on the UC Davis REDcap database using an 
encrypted, password-protected computer at UC Davis Medical Center, division of 
Gastroenterology office located at 2315 Stockton Boulevard, South 3 Room 3016 and 
Ticon I. Only study staff designated for data entry will have access to the REDCap 
database. Upon request, the de-identified data will be exported from the REDCap 
database and distributed to the investigators for analysis.  De-identified data used for this 
study will not be banked for future use. At the completion of the study, all linkage 
between the patient identifiers and the study number will be destroyed. 
 

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10) Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
This research does not involve more than minimal risk to the subject.  
 
The PI affirms to uphold the principle of the subject’s right to protection against invasion 
of privacy. Throughout this study, a subject’s source data will only be linked to the study 
database or documentation via a unique identification number. As permitted by all 
applicable laws and regulations, limited subject attributes, such as sex, age, or date of 
birth, and subject initials may be used to verify the subject and accuracy of subject’s 
unique identification number.  
 
 
11) Withdrawal of Subjects 
 
Participation in the study is completely voluntary, thus patients can withdraw at any time 
during or after the procedure. Written consent will be obtained from all subjects. 
Withdrawing from the procedure has no negative implication on their colon cancer 
screening and subsequent clinical care. If a subject desires to withdraw from the study, all 
information associated with the particular subject will be discarded immediately. 
 
A patient may also be withdrawn from the research at the discretion of the endoscopist or 
PI. The PI may withdraw a subject if there is a clinical suspicion for hereditary polyposis 
syndrome and/or new case of inflammatory bowel disease (IBD) based on the 
colonoscopy. Also, there are scenarios where the regular colonoscope is switched to a 
pediatric colonoscope. This occurs in patients with altered/ post-surgical anatomy, 
preventing completion of the procedure using a standard colonoscope. In these cases, 
subjects may be withdrawn from the study.  
 
12) Risks to Subjects 
 
The attachment device proposed in our study is currently FDA approved for use in 
colonoscopy. There is no added risk to participating subjects. There is an overall minimal 
risk to subjects and that risk is similar to any and all risks for conventional colonoscopy. 
Although we will make every effort to ensure that all patient health information remains 
confidential, there is the risk of loss of confidentiality. 
 

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13) Potential Benefits to Subjects 
 
Subjects may benefit from increased sessile serrated adenoma detection.  
 
14) Multi-Site Research 
 
Only UC Davis Medical Center Endoscopy suites will be involved in this study. 
 
15) Community-Based Participatory Research 
 
Not applicable  
 
16) Sharing of Results with Subjects 
 
Under current standard of practice, patients are contacted by the endoscopist either 
through the phone, mail, my chart or in person during a clinic visit to discuss endoscopic 
and pathology results.  The results of the study will not be shared with subjects until the 
study has been completed and all of the data has been analyzed. 
 
17) Prior Approvals 
 
Not applicable  
 
18) Provisions to Protect the Privacy Interests of Subjects 
 
The only people that will have access to subject personal information are the principal 
investigators, sub-investigators and research personnel during the study period. All 
information collected (including age, gender, smoking status, alcohol consumption, BMI, 
diabetes status, withdrawal time, bowel prep quality, size, number and types of polyps 
removed, cecum intubation time and complications of procedure) will be de-identified.  
 
19) Compensation for Research-Related Injury 
 
No compensation will be provided.  
 
20) Economic Burden to Subjects 
 
Patients presenting for colonoscopies are typically insured and are not expected to pay for 
screening colonoscopies. The study will not provide or pay for the endocuff since it is 
already approved for use at each study site as standard practice. The endocuff is an 
additional tool to detect polyps at the discretion of the endoscopist. There is no additional 
billing code when this device is used, and it is included in the standard screening 
colonoscopy visit. Therefore, there is no expectation that patients who are randomized to 

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the endocuff arm will incur additional costs versus those that are randomized to 
colonoscopy without endocuff.  
 
 
 
21) Drugs or Devices 
 
The Endocuff Vision device being used is FDA approved for use during 
colonoscopy. No investigational devices are being used in this study. 
 
22) ClinicalTrials.gov Registration 
 
FDAAA 801 establishes penalties for Responsible Parties who fail to comply 
withClinicalTrials.gov registration or results submission requirements. Penalties 
include civil monetary penalties and, for federally funded studies, the 
withholding of grant funds. 
 
For additional information on registration and results submissions requirements 
click here.  
If registration is necessary the following are required: 
 
• Registration and, in some instances, submission of results at Clinicaltrials.gov 
• Specific clinicaltrials.gov language in the consent form for this research. The 
language can be found in HRP 502 Template Consent under the heading 
“What happens to the information collected for the research?” 
 
Complete each section below. If you finish a section indicating the research must 
be registered on Clinicaltrials.gov is required you do not have to complete the 
remaining sections.  
 
Section 1:  NIH Funded Studies 
If yes to BOTH, the study must be registered on Clinicaltrials.gov. 
Yes  
 
This study is funded by the NIH. (If this study is not funded by NIH, go to Section 
2.) 
 
One or more human subjects will be prospectively assigned to one or more 
interventions (which may include placebo or other control) to evaluate the effects of 
those interventions on health-related biomedical or behavioral outcomes. 
 
Section 2:  Studies subject to FDA jurisdiction 
If yes to ANY the study must be registered on Clinicaltrials.gov. 
Yes 
 
 
This is a prospective clinical study of health outcomes in human subjects that 

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compares an intervention with an FDA-regulated device against a control. This is 
not a small clinical trial to determine the feasibility of a device, or a clinical trial to 
test prototype devices where the primary outcome measure relates to feasibility 
and not to health outcomes. 
 
This is a pediatric post market surveillance of a device as required under section 
522 of the Federal Food, Drug, and Cosmetic Act. 
 
This is a controlled clinical investigation, other than a phase I clinical 
investigation, of a drug subject to section 505 of the Federal Food, Drug, and 
Cosmetic Act or to section 351 of the Public Health Service Act. 
To view a flowchart describing applicable clinical trials subject to FDA jurisdiction click 
here. 
 
Section 3: Publishing the results 
If yes to BOTH the study must be registered on Clinicaltrials.gov. 
Yes  
 
This study prospectively assigns people or a group of people to an intervention, with 
or without concurrent comparison or control groups, to study the cause-and-effect 
relationship between a health-related intervention and a health outcome. 
 
The PI has access to and control over all the data from the clinical trial and has the 
right to publish the results of the trial and plans to publish the results in a journal 
that follows the ICMJE recommendations.  
This requirement includes studies of behavioral interventions. 
 
Section 4: Registration on Clinicaltrials.gov is not required 
Yes  
 
I have read sections 1-3 above and registration on clinicaltrials.gov is not required 
for this research.  
 
23) Criteria for 10 Year Approval  
 
If yes to all items below this research may qualify for a 10-year approval period. 
 
Yes  
 
This research involves no more than minimal risk. 
 
This research does not receive any federal or state government funding or funding 
from a private funder who requires annual review per contract. 
 
This research is not subject to FDA jurisdiction.  
 
This research does not include prisoners as participants. 
 
This research is not subject to SCRO oversight. 
 
This research is not subject to oversight by the Research Advisory Panel of 
California (RAP of C). 
 
This research does not involve identifiable information held by the State of 

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California Department or Agency 
 
No personnel involved in the design, conduct, or reporting of this research have a 
new unreported related financial interest (RFI) in this study.