Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Adenoma,Colorectal Cancer,Adenoma,Colorectal Polyp,Polyps
PROVIDER: 2275613 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.
| 2264760 | ecrin-mdr-crc
Project description:This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).
| 2260406 | 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: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:OBJECTIVE:Low adenoma detection rates (ADR) are linked to increased postcolonoscopy colorectal cancer rates and reduced cancer survival. Devices to enhance mucosal visualisation such as Endocuff Vision (EV) may improve ADR. This multicentre randomised controlled trial compared ADR between EV-assisted colonoscopy (EAC) and standard colonoscopy (SC). DESIGN:Patients referred because of symptoms, surveillance or following a positive faecal occult blood test (FOBt) as part of the Bowel Cancer Screening Programme were recruited from seven hospitals. ADR, mean adenomas per procedure, size and location of adenomas, sessile serrated polyps, EV removal rate, caecal intubation rate, procedural time, patient experience, effect of EV on workload and adverse events were measured. RESULTS:1772 patients (57% male, mean age 62 years) were recruited over 16 months with 45% recruited through screening. EAC increased ADR globally from 36.2% to 40.9% (P=0.02). The increase was driven by a 10.8% increase in FOBt-positive screening patients (50.9% SC vs 61.7% EAC, P<0.001). EV patients had higher detection of mean adenomas per procedure, sessile serrated polyps, left-sided, diminutive, small adenomas and cancers (cancer 4.1% vs 2.3%, P=0.02). EV removal rate was 4.1%. Median intubation was a minute quicker with EAC (P=0.001), with no difference in caecal intubation rate or withdrawal time. EAC was well tolerated but caused a minor increase in discomfort on anal intubation in patients undergoing colonoscopy with no or minimal sedation. There were no significant EV adverse events. CONCLUSION:EV significantly improved ADR in bowel cancer screening patients and should be used to improve colonoscopic detection. TRIAL REGISTRATION NUMBER:NCT02552017, Results; ISRCTN11821044, Results.
| S-EPMC6352411 | biostudies-literature
Project description:ObjectivesThe Endocuff is a device mounted on the tip of the colonoscope to help flatten the colonic folds during withdrawal. This study aimed to compare the adenoma detection rates between Endocuff-assisted (EC) colonoscopy and standard colonoscopy (SC).MethodsThis randomized prospective multicenter trial was conducted at four academic endoscopy units in Germany.Participants500 patients (235 males, median age 64[IQR 54-73]) for colon adenoma detection purposes were included in the study. All patients were either allocated to EC or SC. The primary outcome measure was the determination of the adenoma detection rates (ADR).ResultsThe ADR significantly increased with the use of the Endocuff compared to standard colonoscopy (35.4%[95% confidence interval{CI} 29-41%] vs. 20.7%[95%CI 15-26%], p<0.0001). Significantly more sessile polyps were detected by EC. Overall procedure time and withdrawal time did not differ. Caecal and ileum intubation rates were similar. No major adverse events occurred in both groups. In multivariate analysis, age (odds ratio [OR] 1.03; 95%[CI] 1.01-1.05), male sex (OR 1.74; 95%CI 1.10-2.73), withdrawal time (OR 1.16; 95%CI 1.05-1.30), procedure time (OR 1.07; 95%CI 1.04-1.10), colon cleanliness (OR 0.60; 95%CI 0.39-0.94) and use of Endocuff (OR 2.09; 95%CI 1.34-3.27) were independent predictors of adenoma detection rates.ConclusionsEC increases the adenoma detection rate by 14.7%(95%CI 6.9-22.5%). EC is safe, effective, easy to handle and might reduce colorectal interval carcinomas.Trial registrationClinicalTrials.gov NCT02034929.
| S-EPMC4255000 | biostudies-literature
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:Background and study aims Endocuff Vision (ECV) increases adenoma detection rate (ADR) in randomized clinical trials; however, observational effectiveness data are lacking. We evaluated the effectiveness, safety, and practical aspects of ECV use in a large screening-related real-world cohort. Patients and methods In this observational study, patients undergoing screening-related colonoscopy from November 2018 to April 2019 comprised the baseline period, and those undergoing it from June to November 2019 comprised the ECV period, where ECV use was discretionary. The primary outcome was ADR, compared: 1) between ECV use and standard colonoscopy across both periods; and 2) between time periods. Secondary outcomes included indication-specific ADR, sessile serrated ADR (SSADR), cecal intubation rate (CIR), procedure times, patient comfort scores, and sedation use. Multilevel logistic regression was performed, yielding adjusted odds ratios (AOR) with 95 % confidence intervals (CIs). Results In 15,814 colonoscopies across both time periods, ADR was 46.7 % with standard colonoscopy and 54.6 % when ECV was used ( P < 0.001). Endoscopists used ECV in 77.6 % of procedures in the ECV period, during which overall ADR rose to 53.2 % compared to 46.3 % in the baseline period ( P < 0.001). ECV use was significantly associated with higher ADR (AOR 1.24, 95 % CI 1.10 to 1.40) after adjusting for relevant covariates including time period. ECV use did not result in lower CIR, longer procedure time, increased sedation use, or poorer comfort scores. Conclusions ECV use is associated with improved ADR without negatively impacting other key procedure and patient-related factors. Future studies should evaluate the cost-effectiveness of incorporating ECV into routine screening-related practice.
| S-EPMC8545492 | biostudies-literature
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:Background and aimsAdenoma detection rate (ADR) in colon cancer screening is most important for cancer prophylaxis. This work is the first three-armed randomised controlled clinical trial aimed at comparing a head-to-head setting standard colonoscopy (SC) with Endocuff-assisted colonoscopy (EC) and cap-assisted colonoscopy (CAC) for improvement of ADR.MethodsPatients from Poland and Germany with independent indication for colonoscopy were randomised into three arms of this trial: EC, CAC and SC. Exclusion criteria were age <18 years, active Crohn's disease or ulcerative colitis, known stenosis and post-colonic resection status.ResultsA total of 585 patients (195 SC, 189 EC and 186 CAC) were enrolled in this study. Indications were not different between the groups (colorectal cancer screening 51%, diagnostic colonoscopy in 31% and post-polypectomy follow-up in 18%; p = 0.94). Withdrawal time was a mean of 7 min in all groups (p = 0.658), and bowel preparation did not differ between the groups. The time to reach the caecum was significantly reduced when using the cap (a mean of 6 min for CAC vs. 7 min for SC; p = 0.0001). There was no significant difference in the primary outcome of the ADR between the groups (EC 32%, CAC 30%, SC 30%; p = 0.815). EC proved to be superior (EC vs. SC) in the sigmoid colon and transverse colon for polyp detection.ConclusionThe use of EC increased the total number of polyps seen during colonoscopy. In contrast to recent studies, no significant improvement of the ADR was detected.
| S-EPMC8259258 | biostudies-literature