Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
Phase: NA
Conditions: Colon Cancer Screening, Colon Polyps, Colon Adenomas, Water Exchange Colonoscopy
Sponsor: University of California, Davis

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Protocol Title: 
Comparison of colon adenoma detection rate using two distal colonoscope 
attachments. 
NCT ID: NCT02665741 
Protocol Date: 8 March 2016 
 
 

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Author of Protocol: 
 
Dr Sooraj Tejaswi, Dr Al-Juburi, Dr Jesse Stondell, Dr Latifat Alli-Akintade, Dr Joseph Marsano 
 
UC Davis Researcher - Yes 
Researcher from other institution 
Private Sponsor 
Cooperative Group 
Other: _________________ 
 
IRB Review History 
N/A 
 
Objectives 
The goal of our study is to compare the effect of two different distal colonoscopy attachments 
on: 
  
(i) Adenoma detection rate 
(ii) Right sided adenoma detection rate 
(iii) Sessile serrate adenoma detection rate 
(iv)Terminal ileum intubation rate 
 
Background 
Although mortality from colon cancer is decreasing, it remains the second leading cause of 
cancer related death in the United States 1. There are multiple factors contributing to this 
decrease, such as increased awareness, improving screening techniques, etc.   
Of the available modalities approved for colon cancer screening in the United States, 
colonoscopy is considered the gold standard. Colonoscopy has the advantage of being both 
diagnostic and therapeutic, allowing the removal of pre-cancerous polyps, before the polyps can 
transform into cancer.  Colonic polyps can occur at any location from the rectum to the cecum. 
Colonoscopy has been shown to be more effective in decreasing incidence of cancer in the left 
colon but remains limited in the detection of right sided polyps /lesions 2.  This difference based 
on location is thought to be due to several reasons. Typically the right side of the colon is less 
clean than the left side during colonoscopy, thereby impairing visualization of polyps. This 
problem has been overcome by incorporating a “split bowel preparation”, which has not become 
standard of care. However, the problem of not being able to visualize polyps behind folds seen in 
the colon persists despite improvements in the quality of cleansing of the colon. Various 
endoscopic technologies have been introduced with the goal of assisting with the manipulation of 
such colonic folds, and thereby reducing chances of missing polyps behind fold.Two such 
colonoscope assisted devices including the distal transparent cap , and the Endocuff device. 
 
 
The Endocuff overtube is a small device with flexible arms arranged in 2 rows. Each row has 8 
short, soft arms projecting away from the device. These arms are used to peel back the colonic 

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folds without causing physical damage to enable visualization behind colonic folds. The use of 
Endocuff overtube has shown promising results in terms of cecal intubation rate and time as well 
as adenoma detection rates 3. 
 
The transparent cap attachment is a clear plastic device that fits at the end of the colonoscope and 
extends a short distance past the tip of the colonoscope.  It aids in the manipulation of folds and 
in maintaining a suitable distance from the mucosa, with the goal of improving visualization. 
Although some studies comparing cap fitted colonoscopy to standard (non- attachment) 
colonoscopies have shown improved adenoma detection 4, others have shown no significant 
benefit 5.   
 
 
Although, these devices have been compared with conventional colonoscopies (i.e without any 
distal attachment), to our knowledge, there are currently no studies that have compared these two 
distal colonoscope attachment devices head-to-head, and none has specifically evaluated effects 
on detection of right sided adenomas. Also, here at UCDavis, these devices are being used 
specifically in diagnostic colonoscopies for removal of large polyps and the choice of which 
specific device used is dependent on level of comfort of the advanced endoscopist. The 
endoscopists participating in our study do not currently use these devices as part of their routine 
colonoscopies, thus it is important to provide head to head comparison of these devices to help 
guide management practice.  
 
Therefore, our goal is to compare the transparent cap fitted, Endocuff fitted and non-cap fitted ( 
standard) colonoscopy in patients presenting to UC Davis Medical Center for screening 
colonoscopies.  
 
Reference 
1) U.S. Cancer Statistics Working Group. United states Cancer Statistics: 1999-2011. Incidence and Mortality Web 
based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and 
Prevention, and National Cancer Institute; 2014. 
2) Hermann Brenner, Michael Hoffmeister, Volker Arndt, Christa Stegmaier, Lutz Altenhofen, Ulrike Haug. 
Protection From Right- and Left-Sided Colorectal Neoplasms After Colonoscopy: Population-Based Study JNCI J 
Natl Cancer Inst (2010) 102 (2): 89-95 doi:10.1093/jnci/djp436 first published online December 30, 2009  
3) Mathieu Pioche,  Minori Matsumoto, Hiroyuki Takamaru, Taku Sakamoto et al. Endocuff®-assisted colonoscopy 
increases polyp detection rate: a simulated randomized study involving an anatomic colorectal model and 32 
international endoscopists. Surgical Endoscopy And Other Interventional Techniques Official Journal of the Society 
of American Gastrointestinal and Endoscopic Surgeons (SAGES) and European Association for Endoscopic Surgery 
(EAES) 2015:4208 . DOI: 10.1007/s00464-015-4208-8 
4) Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: 
a systematic review and meta-analysis. Diseases of the Colon and Rectum 2012; 55(2): 218-225 
5) Harada Y, Hirasawa D, Fujita N, et al. Impact of a transparent hood on the performance of total colonoscopy: a 
randomized controlled trial. Gastrointest Endosc 2009;69:637-446) Dik VK Gralnek IM, Segol O, Suissa A 
Multicenter, randomized, tandem evaluation of EndoRings colonoscopy - results of the CLEVER study. 
Endoscopy. 2015 Jul 28 
 

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Inclusion and Exclusion Criteria 
Our goal is to study patients presenting to UC Davis Medical Center Endoscopy suites for 
screening colonoscopies.   
 
Inclusion criteria:  
All Patients over the age of 50 presenting to Outpatient Gastroenterology labs for screening or 
surveillance colonoscopy located at the UC Davis Endoscopy suites located in Folsom, Elk 
Grove and Sacramento, California between September 2015 and September 2016 will be offered 
this study.  
 
Exclusion criteria:  
(i) Age less than 50 
(ii) Prior history of colon cancer 
(iii) Patients with inflammatory bowel disease 
(iv) 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).  
(v) 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 
(vi) Patients with family history of colon cancer in 1st degree relative below the age of 60 
(vii) 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 
(viii) Patients unable to consent  
(ix) Pregnant patients 
(x) Incarcerated patients  
 
Number of Subjects 
144 patients will be enrolled 
 

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Recruitment Methods 
Patients presenting to the UC Davis Medical Center Endoscopy Suites located in Folsom, Elk 
Grove and Sacramento for screening colonoscopy with be recruited on the day of their 
procedure.  
 
Typically, these patients are either referred to UC Davis for screening colonoscopy or already 
being followed here. 
 
One of our study investigators (listed on personnel sheet) will review the history of patients 
scheduled for their colonoscopies. Patients that meet eligibility requirements will be contacted by 
telephone within a week prior to their scheduled procedure (see attached telephone script). The 
contact information collected will used solely for this purpose. This will provide an opportunity 
for the patient to have initial study information as well as sufficient time to decide on whether or 
not they would be interested in participating in the study. Any personal health information 
collected will be destroyed at the earliest opportunity 
 
A written information sheet (see form 502) containing important study information will be given 
to patient prior to or during their check in process. After adequate time has been provided to the 
patient to read and understand the study details, the physician performing the patient’s procedure 
will explain the study and answer all questions pertaining to the study. Patients interested in 
participating will be consented.  
Patients not interested in participating will proceed with their routine scheduled procedure 
without the use of any distal attachment on the colonoscope.   
 
As part of the recruitment process, we would need to preview records of scheduled patients 
including PHI- name, medical record number and age, past medical and family histories as well 
as contact information. Given that this is the pre-selection review, it would be impossible to 
collect this information / screen for patients that meet criteria for inclusion without access to the 
patient information. For patients that do meet requirement for enrollment, we will be contacting 
them by phone to provide initial study information.  
 
Information collected, including contact information will not be disclosed to any other persons or 
organization and information collected will not be re-used for any purpose outside of the study.   
 
Compensation to the Subjects 
There will be no compensation to the participants.  
  
Study Timelines 
Timeline for enrolment of subjects will be September 2015 – September 2016. This will be a 
one-time participation during the date of their procedure only. 
 
Patient medical records will be accessed within 4 weeks of their colonoscopy for collection of 
final pathology report (adenomatous vs non adenomatous polyps). Patients will not be contacted 
afterwards for research purposes. They will only be contacted by their endoscopist for 
communication of colonoscopy results per regular standard practice at UC Davis.  
 

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Study Endpoints 
 
Primary Endpoint 
-Adenoma detection rate 
 
Secondary Endpoints 
-Proximal adenoma detection rate 
-Polyp detection rate 
-Cecal intubation rate 
-Intubation time 
-Withdrawal time 
-Major complication rate (includes perforation, bleeding requiring transfusion). 
 
Procedures Involved 
Our proposed study is a randomized control trial in which patients are randomized in a single-
blinded fashion into one of 3 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 transparent cap attachment and a third arm will 
undergo their colonoscopy with the Endocuff attachment. 
 
All methods (colonoscopy without any attachment, colonoscopy with transparent cap attachment 
and colonoscopy with Endocuff attachment) are approved standard of care options, and are 
already in clinical use.  
 
Data that will be reviewed as part of the study includes the number of polyps, location of polyps 
removed, size of the polyps removed, histopathology of the polyps, and whether or not the 
terminal ileum was intubated if necessary. These are data points that are routinely collected and 
reported as part of regular care of patients.  
Each study patients will be assigned a study number, which will be de-identified. No patient 
identifiers will be collected as part of the study.  
 
Data and Specimen Banking 
Data collected will be saved on an encrypted, password-protected computer at UC Davis Medical 
Center, division of Gastroenterology office located at 2315 Stockton Boulevard , South 3 Room 
3016. 
 
Data Management and Confidentiality 
Data collected will be saved on 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. Also, each study patients 
will also be assigned study number, which will be de-identified. This information will only be 
accessible by the investigators involved in the study (listed on form 211). 
 
The data collected will be analyzed using one way ANOVA. To detect an effect size of 20%, 
with a power of 0.809, we would need 42 subjects in each study arm. We therefore aimed to 

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enroll 48 subjects into each arm (total of 4 arms) to ensure we have enough subjects in each arm 
to detect an effect if present. An interim analysis to test for futility will be done after 6 months. 
 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
This research does not involve more than minimal risk to the subject 
 
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.  
A patient may 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 / 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. In these cases, subjects may be withdrawn from the study.. 
This may be needed in patients with difficult anatomy or post-surgical anatomy preventing 
completion of the procedure using a standard colonoscope.  
 
 
Risks to Subjects 
The attachment devices proposed in our study are currently approved for use in colonoscopy. 
Although we will make every effort to ensure that your information remains confidential, there is 
the risk of loss of confidentiality 
 
Potential Benefits to Subjects 
Subjects may benefit from increased adenoma detection.  
 
Vulnerable Populations 
Vulnerable populations are not included in this study 
 
Multi-Site Research 
Only UC Davis Medical Center Endoscopy suites will be involved in this study 
 
Community-Based Participatory Research 
Not applicable 
 
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. 
 
Setting 

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Our research will take place at the University of California, Davis Medical Center outpatient 
Endoscopy Suites. These are located in Elk Grove, Folsom and at the main hospital here in 
Sacramento.  
 
Potential subjects are patients that are presenting for outpatient screening colonoscopies.  
 
Resources Available 
The Endoscopists performing these procedures are board certified Gastroenterologists, with 
knowledge regarding the colonoscopes and attachment devices. They will provide potential 
subjects with the consent forms as well as answer any questions that they may have regarding the 
procedure.  
 
There are no expected physical or emotional consequences as a result of participating in this 
study 
 
Prior Approvals 
Not applicable 
 
Provisions to Protect the Privacy Interests of Subjects 
The only people that will have access to subject personal information are the principal 
investigators during the study period. All information collected (including age, gender, number 
and types of polyps removed, cecum intubation time and complications of procedure) will be de-
identified immediately after data collection.  
 
Compensation for Research-Related Injury  
No Compensation provided  
 
Economic Burden to Subjects 
Patients presenting for colonoscopies are typically insured and are not expected to pay for 
screening colonoscopies. The distal attachment device will be provided at no additional cost to 
the patients, thus there will be no additional economic burden to the subjects 
 
Consent Process 
Currently, the standard of practice is to obtain 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.  
 
For those choosing to participate in our study, an additional consent form will be needed. 
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 via telephone by Dr Alli-Akintade or Dr 
Marsano or Dr Tejaswi. Information regarding the procedure (including the goal of the study) 
will be discussed with them to provide sufficient time prior to their procedure for them to 
consider participating or not participating.  Once the subject has been contacted by telephone and 
has agreed to participate, the investigators will obtain the subject’s address and mail them a copy 
of the consent form (if they are contacted three weeks before the procedure) or obtain the 

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subject’s email address and send them a copy of the stamped consent form via email (if they are 
contacted fewer than three weeks before the procedure) 
On the day of the procedure, the endoscopists will discuss further with the patients about the 
procedures - including consent, medication/ history review as well as discussions about the risks 
and benefits of the procedure. This conversation typically occurs in a quiet corner/ 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 
procedures for the consents to be done.  
 
 
Please see attached Consent form (HRP-502).  Non English speakers 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 will not be included in their study.  
 
HIPAA Authorization for Research 
Consent will be obtained from all participants and patients not able to consent (such as 
cognitively impaired adults) will be excluded from the study. Children are also not 
included in this study 
 
Process to Document Consent in Writing 
Please see attached HRP form 502 
 
Drugs or Devices 
The attachment devices being used are approved for use during colonoscopies. No 
investigational devices are being used in this study. 
 
 
Applicable to: 
FDA Regulation 
IND 
studies 
IDE 
studies 
Abbreviated 
IDE studies 
21 CFR 11 
• Electronic Records and Signatures 
X 
X 
 

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21 CFR 54 
• Financial Disclosure by Clinical 
Investigators 
X 
X 
 
21 CFR 210 
• Current Good Manufacturing Practice in 
Manufacturing, Processing, Packing, or 
Holding of Drugs 
X 
 
 
21 CFR 211 
• Current Good Manufacturing Practice for 
Finished Pharmaceuticals 
X 
 
 
21 CFR 312 
• Investigational New Drug Application 
X 
 
 
21 CFR 812 
• Investigational Device Exemptions 
 
X 
X 
21 CFR 820 
• Quality System Regulation 
 
X