Comparison of AMR and ADR Between Endocuff Vision-assisted and Conventional Colonoscopy: a Multicenter Randomized Trial
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Neoplasms
PROVIDER: 2264782 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:The goal of distal attachment devices is to enhance an endoscopist’s adenoma detection rate (ADR). A device called EndoCuff Vision (ECV) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing ADR. ECV has been shown to be efficacious in improving ADR within the context of randomized trials. However, no ‘real-world’ studies have been published assessing the effectiveness of ECV in non-trial settings. The primary objective of this study is to assess the effect of ECV use on ADR in a routine screening-related population.
| 2339765 | ecrin-mdr-crc
Project description: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
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Project description:This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).
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Project description: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.
| 2238186 | ecrin-mdr-crc
Project description:In European countries, colorectal cancer (CRC) represents an important public health problem. It is widely held view that most carcinomas develop from an adenoma-carcinoma progression.
Adenoma detection rate (ADR) is a marker of high quality colonoscopy and it was inversely associated with the risk of interval colorectal cancer, advanced-stage interval cancer, and fatal interval cancer after colonoscopy.
Although colonoscopy is considered the gold standard for adenoma detection, it has shown some limits, so industry has aimed at increasing detection rate of adenomas providing new technologies, most of witch to detect lesions located in blind spots.
ARC Endocuff Vision (AEV), the second generation of Endocuff, represents a new generation of these devices, thus assessing the diagnostic sensibility of ARC Endocuff Vision assisted colonoscopy (EAC) is an interesting challenge.
Aim of the study is to compare ADR of EAC versus standard colonoscopy among FIT positive subjects in the context of CRC screening programs.
| 2279651 | ecrin-mdr-crc
Project description:Interventions: Colonoscopy with Endocuff or conventional colonoscopy.
Primary outcome(s): 1. Mean number of adenomas per patient;
2. Adenoma detection rate (percentage of colonoscopies where at least one adenoma is found).
Study Design: Randomized controlled trial, Open (masking not used), Active, Parallel
| 18180 | ecrin-mdr-crc
Project description:Protocol Title: Three Arm Prospective Randomized controlled trial of High-Definition White-light colonoscopy versus High-Definition White-light colonoscopy with Reveal Distal Attachment Cap versus High-Definition White-light colonoscopy with Endocuff Vision for the detection of colorectal adenomas
Hypothesis: Detection rate of adenomas in patients will be higher in procedures performed with High-Definition White-light (HDWL) colonoscopy with Reveal distal attachment cap and HDWL colonoscopy with Endocuff Vision compared to HDWL colonoscopes alone
Design: Multicenter, Prospective, randomized controlled study
Primary Aim: To compare the proportion of subjects with at least one adenoma detected during HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
Secondary Aims: To compare the number of adenomas detected per subject with HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
To compare the detection rates for polyp subtypes (including advanced adenomas, serrated polyps, right sided adenomas, etc.), cecal intubation rate, insertion time, withdrawal time, and complications of HDWL colonoscopy versus HDWL colonoscopy with Reveal distal attachment cap versus HDWL colonoscopy with Endocuff Vision.
| 2305759 | ecrin-mdr-crc
Project description:Colorectal cancer is the 2nd most common cause of death by cancer. Screening is therefore essential, with a positive impact for prevention, and in the visualization and removal of colonic adenomas, pre-cancerous lesions of colorectal cancer.
The colonic adenoma detection rate (CADR), the gold standard for colonoscopy screening and screening studies, is the ratio of the number of colonoscopies with at least one histologically verified colonic adenoma to the total number of colonoscopies performed in a center. It varies between 25 and 45% depending on the center. There is a large inter-operator CADR variability, which has been linked to an increased incidence and excess mortality in colorectal cancers.
To improve this detection rate, several innovative techniques have been developed:
The endoscopic cap helps improve this detection rate: it is a 2cm tip with double row of plastic wings, fixed to the distal end of the colonoscope, which acts by unfolding the colonic haustrations allowing a better visualization of adenomas, and more particularly those of sessile morphology and sigmoidal location. Several multicenter studies have shown an improvement in the adenoma detection rate with this device compared to screening colonoscopy alone, with an adenoma detection rate optimization of 14%. Since then other devices, such as the Endocuff, have emerged with comparable efficacy. The Medtronic© GI GENIUS system integrates artificial intelligence (AI) to assist in the detection of polyps. It automatically identifies these precancerous lesions in real time.
The study investigators previously performed a retrospective pilot study (COLODETECT), comparing colonoscopy alone as a control group, against AI alone and against the combined cap + AI. This study showed encouraging results in terms of colonic adenoma detection rate (60% for the AI + cap group versus 37% for the AI alone group versus 33% for the colonoscopy alone group, p=0.037) However, it requires a higher level of evidence to be validated in practice. This prospective COLODETECT2 study estimated an a priori expected difference between A.I. - Cap and A.I. alone of about 15% CADR.
The GI GENIUS artificial intelligence system and the ENDOCUFF VISION endoscopic cap have separately proven their effectiveness in terms of colonic adenoma detection compared to colonoscopy alone. However, some limitations remain: existence of false positives (mucosal folds, residues), some morphological types still difficult to recognize (scalloped adenomas), non visualized colonic lesions.
This study therefore focuses on the possible complementarity of these 2 medical devices, in order to maximize the detection rate of colonic adenomas, and thus overcome the limitations of these two techniques by optimizing the visualization of these precancerous lesions, and consequently increasing the impact of colorectal cancer screening.
The study authors hypothesize that the combination of GI GENIUS AI coupled with the ENDOCUFF VISION endoscopy cap provides a better colonic adenoma detection rate (CAD) during colonoscopy than either GI GENIUS AI alone or the ENDOCUFF VISION cap alone.
| 2752527 | ecrin-mdr-crc
Project description:Interventions: This is a back-to-back crossover tandem colonoscopy study comparing the Endocuff device and standard care (high definition white light endoscopy with chromoendoscopy) compared with standard care alone for dysplasia surveillance in patients with inflammatory bowel disease. The Endocuff device is a small cap that attaches to the end of a standard colonoscope. Small, soft, finger-like projections extend from this cap on withdrawal of the colonoscope with the aim of flattening mucosal folds, anchoring the colonoscope and thus improving rate of dysplasia detection. The colonoscopies will be performed by endoscopists with training and experience in performing dye-spray chromoendoscopy, interventional endoscopy and who have had previous experience using the Endocuff device. All patients will receive two passes with the colonoscopy (one standard, and one with Endocuff) during the same anaesthetic, on the same day. Approximate length of each procedure will be about 15-20 minutes with a few minutes between crossover. This will occur at an endoscopy suite within Eastern Health. Follow-up will be via phone call at days 1, 7 and 21 post-procedure.
Primary outcome(s): Dysplastic lesion miss rate: as defined as the number of lesions detected on the second colonoscopy which was missed during the first colonoscopy (regardless of Endocuff use or standard colonoscopy)[During colonoscopy];Dysplasia detection rate: as defined as the number of participants with one or more dysplastic lesions (adenomas with low-grade dyspalasia, adenomas with high-grade dysplasia, carcinoma insitu, invasive carcinoma)[During colonoscopy and confirmation with histology after colonoscopy]
Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Safety/efficacy
| 2466130 | ecrin-mdr-crc
Project description:The hypothesis of the present study is to demonstrate that ENDOCUFF VISION increases the detection rate of adenomas thanks to the improved visibility produced by the retraction of the folds and stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF VISION on the average number of adenomas detected per patient (MAPP) as well as serrated adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety of its use will be estimated.
| 2330939 | ecrin-mdr-crc