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Colonic Polyps clinical trials

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NCT ID: NCT03846609 Completed - Colonic Polyp Clinical Trials

Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD

Start date: February 19, 2019
Phase: N/A
Study type: Interventional

The purpose of this randomized study is to compare ESD procedural time and cost facilitated with a dual balloon accessory device versus ESD procedures performed without the accessory device. Study is designed to detect if the double balloon interventional platform helps to perform removal of benign complex colonic lesions safer and in more efficient way.

NCT ID: NCT03840590 Completed - Clinical trials for Colorectal Neoplasms

Adenoma Detection Rate Using AI System in China

SinoAIADR
Start date: July 10, 2019
Phase: N/A
Study type: Interventional

The primary aim of this study is - to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Artificial Intelligence 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

NCT ID: NCT03839277 Suspended - Clinical trials for Colorectal Neoplasms

Adenoma Detection Rate Using Endocuff Vision in China

SinoEVADR
Start date: June 12, 2019
Phase: N/A
Study type: Interventional

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

NCT ID: NCT03833492 Completed - Colonic Polyps Clinical Trials

UEMR vs. CEMR for Diminutive Non-pedunculated Colorectal Polyps

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

This clinical trial is being conducted to compare the efficacy and safety of two standard methods of polypectomy,Conventional Endoscopic Mucosal Resection(EMR)and Underwater Endoscopic Mucosal Resection(UEMR),for small colorectal polyps.

NCT ID: NCT03826069 Recruiting - Colonic Polyp Clinical Trials

Impact of Augmented Reality in Polypectomy Skills Acquisition in Simulation-based Endoscopy Training

Start date: June 17, 2019
Phase: N/A
Study type: Interventional

Simulation-based training (SBT) is a safe and effective strategy for improving skills development in gastrointestinal endoscopy. The use of curricula based on progressive learning, as well as comprehensive structured curricula, have been demonstrated to be effective in enhancing simulation-based training. With current advancements in technologies, another possible enhancement to SBT is the use of augmented reality (AR). To date, no other studies have examined the benefits of AR technology in endoscopy training. This study aims to evaluate the effectiveness of a simulation-based AR curriculum in developing technical skills, self-assessment accuracy, and clinical performance; as compared to a conventional simulation curriculum. Thirty six novice endoscopists will be recruited from the gastroenterology and general surgery programs at the University of Toronto. Participants will be randomized and assigned to two groups. The Conventional Simulation Training Curriculum group will receive 6 hours of simulated training, with expert feedback, and four 1-hour didactic teaching sessions. The AR Training Curriculum group will receive the same number of training hours and didactic sessions as the control group. The main difference is the use of superimposed videos to guide the intervention group through simulated polypectomy cases. During the didactic teaching sessions, the intervention group will also receive a brief introduction to principles of AR and its uses for endoscopy simulation. Participants will be trained to perform colonoscopies on two validated simulator models: (1) a bench-top colonoscopy simulator; and (2) the EndoVR® virtual reality simulator. Performance will be assessed before training (pre-test), immediately after training (acquisition post-test) and 4-6 weeks after training (retention test). On the same day as the retention test, the participants will perform two live colonoscopies and use a mechanical polypectomy simulation test (transfer tests), assessed by two blinded expert endoscopists. The main hypothesis of this study is that novices trained under the AR-enhanced curriculum will have better technical skill performance during simulated polypectomies and live colonoscopies.

NCT ID: NCT03783156 Completed - Clinical trials for Gastrointestinal Bleeding

Polypectomy With Hot vs Cold Snare in Small Colonic Lesions

Polypech-c
Start date: February 18, 2019
Phase: N/A
Study type: Interventional

Colonoscopy is the technique of choice for the diagnosis and prevention of colorectal cancer (CRC). The identification and extirpation of adenomas decreases the incidence of CRC by up to 76%. More than 70% of the excised lesions are less than 10 mm. There is controversy about the technique to be used (resection with cold vs hot snare) in lesions of 5-9mm. Both use a polypectomy snare. The cold snare cuts by friction, while the hot snare uses electrical current. We propose a multicenter randomized clinical trial comparing both endoscopic techniques. At least 394 injuries per group will be included, randomizing patients to whom a diagnostic colonoscopy is requested for symptoms, screening or revision protocols. Randomization will be performed stratified by center. The primary objective is the proportion of incomplete polypectomies, which will be analyzed centrally from random biopsies of the edges of the lesion. As secondary objectives, we will compare the proportion of immediate and delayed hemorrhagic complications, the evolution of postprocedural abdominal pain and the factors associated with incomplete excision in each group and the factors associated with a failed cold polypectomy. The analysis of the primary objective will be carried out by means of the z test of homogeneity without using the correction of Yates, estimating the confidence interval of the difference between both groups. The analysis will be carried out by intention to treat and per protocol.

NCT ID: NCT03758872 Completed - Colonoscopy Clinical Trials

CUFF-assisted Colonoscopy vs Standard Colonoscopy

CUFF-TROCADERO
Start date: October 25, 2018
Phase:
Study type: Observational

The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate in routine colonoscopy. This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group

NCT ID: NCT03746171 Completed - Colonic Polyp Clinical Trials

Blue Light Imaging (BLI) for Optical Diagnosis of Colorectal Polyps

BIRD
Start date: January 1, 2019
Phase:
Study type: Observational

Several imaging technologies have been developed in order to enable the endoscopists to differentiate neoplastic from non-neoplastic lesions. The real-time prediction of polyps histology is clinically relevant as diminutive polyps represent the majority of polyps detected during colonoscopy and have a very low risk of harboring advanced histology or invasive carcinoma. Thus, an optical diagnosis would allow diminutive polyps to be resected and discarded without pathological assessment or left in place without resection, with an enormous cost-saving potential. Recently, the American Society of Gastrointestinal Endoscopy (ASGE) has set the Preservation and Incorporation of Valuable endoscopic Innovation (PIVI) which defined accuracy threshold to be met, in order to consider a new technology ready to be incorporate into clinical practice. Blue Light Imaging (BLI) is a new chromoendoscopy technology integrated in the latest generation ELUXEOTM 7000 endoscopy platform (Fujifilm Co, Tokyo, Japan), based on the direct (i.e. not filtered) emission of blue light with short wavelength (410nm), that enhances visibility of both microvascular and superficial mucosal pattern. In a recent randomized trial BLI was superior to high-definition white light (HDWL) in the real time characterization of subcentimetric and diminutive colonic polyps. Nevertheless, in this study the paucity of diminutive rectosigmoid polyps analyzed does not allow to draw definite conclusions as the meeting of PIVI thresholds are concerned. Similarly, the low numbers of patients evaluated limited the per-patient analysis. Therefore further studies adequately powered to this clinically end-point were advocated. Additionally, when the study was performed a BLI dedicated classification for optical diagnosis of colonic polyps was not available, whereas recently a specific classification (the BLI Adenoma Serrated International Classification-BASIC) has been developed and a specific training set has been settled. In the present study the investigators prospectively evaluate whether the use of BLI-assisted optical characterization of diminutive polyps using BASIC classification by specifically trained endoscopists may met PIVI thresholds and particularly if it allow the endoscopists to achieve > 90% correct assignment of post-polypectomy surveillance intervals when combined with the histopathology assessment of polyps >5 mm in size.

NCT ID: NCT03690297 Completed - Colonic Polyp Clinical Trials

Linked Color Imaging (LCI) for Colorectal Adenoma Detection

Start date: October 15, 2018
Phase: N/A
Study type: Interventional

Linked color imaging (LCI) is newly developed image-enhancing endoscopy technology that differentiates the red color spectrum more effectively than white light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. This technology, combined in the latest generation Fujifilm's endoscopes (Fujifilm Co, Tokyo, Japan) with new high-performance LED illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data available regarding colorectal polyp or adenoma detection with LCI are encouraging but are scanty and limited to back-to back studies. This two parallel arms, randomized, multicenter trial is aimed at evaluating whether LCI is superior to WL endoscopy in terms of adenoma detection

NCT ID: NCT03688906 Completed - Colo-rectal Cancer Clinical Trials

AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test

Start date: January 12, 2018
Phase:
Study type: Observational [Patient Registry]

Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay to detect colorectal cancer by collecting blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas.