Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Colorectal Neoplasms

Adenoma

Colonic Polyps

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Intestinal Polyps

Pathological Conditions, Anatomical

Participants in this arm undergo Endocuff Vision-assisted colonoscopy

Participants in this arm undergo standard colonoscopy

Endocuff Vision is attached to the tip of colonoscope before intubation.

Endocuff Vision

En-Da YU

The primary aim of this study is

- to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR).

Other aims include to explore the data below when Endocuff Vision is used.

Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT

Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 5 centres, recruiting a total of 1200 participants.

Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).

Adenoma Detection Rate Using Endocuff Vision in China

ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.

PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.

Sixth Affiliated Hospital, Sun Yat-sen University

Shanghai Zhongshan Hospital

Tianjin People's Hospital

Tianjin Nankai Hospital

Changhai Hospital

Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope

Patients in this arm will receive their screening sigmoidoscopy without the Endocuff on the scope

The EndocuffTM (ARC Medical Design Ltd and Diagmed, UK) is a device (CE marked in UK) made of a soft plastic material with a unique dynamic shape. Endocuff Vision™ is placed snugly around the colonoscope tip prior to insertion. It does not project beyond the tip of the scope, providing an unrestricted view. It helps anchor the scope tip against the bowel wall to provide a stable platform of access. The soft, elastic projections are pushed back (recoiled) towards the scope shaft during insertion but evert during withdrawal to hold colon folds away from the field of view.

Colin J Rees, MBBS MRCP FRCP

This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.

Colorectal cancer (CRC) is the fourth most common cancer in the UK with 40,000 new cases diagnosed annually. Most CRCs arise from the adenoma-carcinoma sequence which is a process that can take up to 10 years. Population screening programmes allow for earlier detection and removal of adenomas that may become malignant over time thus reducing CRC mortality. The English Bowel Scope Screening (BSS) programme began in 2013 and invites adults aged 55 and above for a one-off flexible sigmoidoscopy. The aim of the BSS programme is to reduce CRC development via the adenoma-carcinoma sequence through the detection and removal of adenomas from the left side of the colon. A large UK study has shown that offering one-off flexible sigmoidoscopy screening with adenoma clearance to adults aged 55-64 years reduced CRC incidence by 23% and mortality by 31%. Adenoma detection rate (ADR) is the most important marker of mucosal visualisation and is a surrogate marker of high quality colonoscopy. Data from colonoscopy studies have illustrated that a 1% increase in ADR is associated with a 3% decrease in interval colorectal cancer. In the BSS programme, ADR is comparatively lower the that shown in the initial sigmoidoscopy screening trials with a wide variation between endoscopists. Another marker that is often used is adenoma miss rates which also demonstrate a wide variation in clinical practice. Reasons for lesions not being detected at flexible sigmoidoscopy can be extrapolated from colonoscopy data and include; suboptimal technique; shorter withdrawal time; inadequate bowel preparation; presence of flat, depressed or subtle lesions; and the inability to visualise the proximal side of haustral folds, flexures (blind spots) and rectal valves. With the aid of the colonoscopic cuff Endocuff Vision®, the investigators aim to improve visualisation of the colonic mucosa by flattening colonic folds and manipulating them away from the field of forward view the investigators hypothesise that the Endocuff Vision® will improve adenoma detection rates by providing better fold retraction, a wider field of view and better scope tip stabilisation. This clinical randomised study will be conducted in subjects referred and scheduled for screening flexible sigmoidoscopy via the NHS English Bowel Scope Screening (BSS) Programme and will compare Endocuff Vision®-Assisted Flexible Sigmoidoscopy (EAFS) with Standard Flexible Sigmoidoscopy (SFS).

BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

Proportion of examinations expressed as a percentage where at least one adenoma is found

Number of adenomas found in each procedure

Length of procedure in minutes and seconds

Number of additional colonoscopies required

ARC Medical Design Ltd

Norgine

South Tyneside and Sunderland NHS Foundation Trust

Standard colonoscopy with no device attachments

Colonoscopy with Endocuff Vision attached to distal end of scope

Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.

Douglas K Rex, MD

This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times

De-identified data can be shared in the future upon request.

Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.

Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.

Total procedure time is the time from the initial insertion through the complete withdrawal of the scope

The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.

Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.

Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision.

The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality.

The quality of the bowel preparation is assessed by the attending gastroenterologist.

Indiana University

Distinguished Professor

Control Arm (Standard Colonscopy)

Colonoscopy with Endocuff Vision attached to distal end of scope

Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.

Total

Age, Continuous

Sex: Female, Male

White

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Gastroenterology fellows assisting in insertion

Screening

Surveillance

Procedure Indication

Examiners were not blinded to the device used. Only 2 examiners with experience with the device participated in the study so generalizability of the results is unknown.

Data was not collected on other potential confounders like smoking or BMI.

Rachel Lahr

Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)

Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)

Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)

Adenomas

Sessile serrated polyps

Detection Rates

Polyps Per Colonoscopy

Boston Bowel Preparation Score

Overall Study

Use artificial intelligence-assisted colonoscopy with Endocuff Vision

Use artificial intelligence-assisted colonoscopy alone

Use standard colonoscopy without artificial intelligence-assisted colonoscopy or Endocuff Vision

ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma

Artificial intelligence

Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma

Endocuff vision

High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma

High-definition endoscope

Ying Nan Tsai, MD

Wen-Lun Wang, Ph.D

Ying Nan Tsai, M.D

Adenoma detection rate (ADR) is considered the single most important quality measure in colonoscopy and a higher ADR can reduce the risk of interval colorectal cancer (CRC). Several kinds of new endoscopes and accessories have been accessed to investigate the abilities of improving the ADR. Artificial intelligence (AI) and Endocuff vision are promising new devices to improve the ADR. However, the effect of combining AI and Endocuff vision on ADR remains unclear. The aim of this prospective randomized study is to compare the ADR of AI plus Endocuff vision, AI alone and standard colonoscopy examination.

This is a prospective single-blinded randomized controlled trial of three different types of colonoscopy examinations by 1:1:1 ratio. We use EndoAim AI (ASUS, Taiwan) and Endocuff vision (Olympus, UK) assisted colonoscopy in the first group. We use AI assisted colonoscopy in the 2nd group. We use standard colonoscopy in the 3rd group.

Eligible patients are older than 40 years old and receive colonoscopy for either symptomatic or screening/surveillance. All endoscopists should receive training on EndoAim AI systems and Endocuff vision. During the procedure, experienced endoscopists use high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) under white light and insert to the cecum in the three different groups. The cecal intubation is confirmed by the identification of ileocecal valve and appendiceal orifice.

The Boston Bowel Preparation Scale is used for grading the bowel preparation quality. The size (compared with biopsy forceps), location and morphology of polyps are recorded by the independent endoscopist. All polyps ae removed by either biopsy or polypectomy. The insertion and withdrawal time are measured. The time of the polypectomy site is not included in the withdrawal time.

Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

Comparison of The Adenoma Detection Rate Between Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision and Standard Colonscopy: A Randomized Controlled Study

The proportion of patients with at least one adenomas

The proportion of patients with at least one polyp

The proportion of patients with at least one sessile serrated adenoma

The proportion of patients with at least one sessile serrated polyp

The proportion of patients with at least one advanced adenoma

The total number of polyp or adenoma per patient

Chung Shan Medical University

E-DA Hospital

Orange

Wee Sing Ngu, MBChB, MRCS

Gayle Clifford, BSc

John Silcock, MBBS, FRCP

Matthew Rutter, MBBS, FRCP

Brian Saunders, MBBS, FRCP

Arvind Ramadas, MBBS, FRCP

Arvind Ramadas, MBBS,FRCP

Thomas Lee, MBBS, FRCP

Colin Rees, MBBS, FRCP

John Painter, MBBS, FRCP

The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.

Bowel cancer is common in the United Kingdom, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel and find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy (via the symptomatic service, surveillance procedures, and the Bowel Cancer Screening Programme) will be invited in 7 centres (a mixture of specialist centres and district general hospitals), recruiting a total of 1772 participants.

Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.

A difference in mean adenomas detected per procedure between both groups

The rate of cuff exchange (that is, how often the cuff has to be removed) between both groups

Duration of complete withdrawal time in procedures where no polyps are detected between both groups

Patient satisfaction measured from no pain (0) to severe pain (3), episodes of discomfort from no discomfort (0) to frequent (more than 4 times)(3), length of discomfort from no discomfort (0) to more than 1 minute(3).

Increase in surveillance colonoscopies due to increased adenoma detection rate in terms of number of potential follow up procedures based on British Society of Gastroenterology adenoma surveillance guidelines in both groups

Number of of proximal sessile serrated polyps in both groups

Distribution of polyps in the colon in both groups by location

Adenoma detection rate of BCSP and non-BCSP colonoscopists

Adenoma detection rate (ADR) of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR.

Baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where Endocuff Vision was not used.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adenoma Detection Rate Using Endocuff Vision in China	NCT03839277	Colorectal Neop... Colonic Polyp Adenoma	Endocuff Vision	45 Years - 80 Years	Changhai Hospital
BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities	NCT03072472	Colorectal Neop... Colonic Polyp Adenoma Neoplasia GI Digestive Syste... Intestinal Neop... Neoplasms, Glan... Digestive Disea... Intestinal Dise... Colonic Disease... Rectal Diseases Intestinal Poly... Polyps Pathological Co...	Endocuff Vision	55 Years - 61 Years	South Tyneside and Sunderland NHS Foundation Trust
Standard Colonoscopy Versus Colonoscopy With Endocuff Vision	NCT03361917	Colorectal Poly... Colorectal Aden... Colon Cancer	Endocuff Vision	40 Years -	Indiana University
Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision	NCT05863208	Adenoma Detecti...	Artificial inte... Endocuff vision High-definition...	40 Years -	E-DA Hospital
Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities	NCT02552017	Colorectal Neop... Colonic Polyps Adenoma	Endocuff Vision	18 Years -	South Tyneside and Sunderland NHS Foundation Trust
Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities	NCT02552017	Colorectal Neop... Colonic Polyps Adenoma	Endocuff Vision	18 Years -	South Tyneside and Sunderland NHS Foundation Trust

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