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Colonic Polyps clinical trials

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NCT ID: NCT05822895 Recruiting - Colonic Polyp Clinical Trials

Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy

COPILOT
Start date: January 2, 2023
Phase:
Study type: Observational [Patient Registry]

Background: Removal of adenomatous polyps during colonoscopy is associated with long-term prevention of colorectal cancer-related deaths. Recently, there have been much interest in the use of artificial intelligence (AI) platforms to augment the routine endoscopic assessment of the colon to enhance adenoma detection rate (ADR). To date, computer assisted detection of polyps (CADe) have been shown to be safe, with a significant increase in ADR, without any concomitant increase in post-procedural complications. Aims: The investigators aim to evaluate the use of GI GeniusTM Intelligent Endoscopy Module in a multi-ethnic Asian population (Singapore) to increase in ADR and adenoma detected per colonoscopy (ADPC)to justify its effectiveness as an adjunct in polyp detection and training for colonoscopy. Methods: This study will be a single-institution cohort study, conducted over a 2-year period. Sengkang General Hospital (SKH) does an estimated 12,500 colonoscopies per year, with an average of 1,040 colonoscopies performed every month. Thus, given the case volume, the investigators expect to detect differences in ADR amongst endoscopists if any during this study period. As part of the subgroup analysis, the investigators also aim to compare the ADR rates of trainee endoscopists with and without the GI GeniusTM Intelligent Endoscopy Module to ascertain its utility as an education tool/training adjunct

NCT ID: NCT05784935 Not yet recruiting - Clinical trials for Artificial Intelligence

Intelligent-C Endoscopy Module for Real-time Detection of Colonic Lesions

iIDEAS/RTD
Start date: March 20, 2023
Phase:
Study type: Observational

To conduct an single blinded, non-randomized, prospective, single center trial to validate the performance of a novel state-of-the-art Artificial Intelligence model (AI-Model) for colorectal lesion detection during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Consecutive patients referred for a screening, surveillance or diagnostic colonoscopy will be included

NCT ID: NCT05776381 Not yet recruiting - Colorectal Cancer Clinical Trials

The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

Management of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual tumor or lymphatic spread. As surgical management entails risks of complications and watchful waiting management entails risks of residual disease or recurrence, a clinical dilemma arises when choosing a management strategy. Shared decision making (SDM) is a concept that can be used in preference sensitive decision making to facilitate patient involvement, empowerment, and active participation in the decision making process. This is a clinical multicenter, non-randomized, interventional phase II study involving Danish surgical departments planned to commence in the first quarter of 2024. The aim of the study is to examine whether shared decision making and using a patient decision aid (PtDA) in consultations affects patients' choice of management compared with historical data. The secondary aim is to investigate Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) using questionnaire feedback directly from the patients.

NCT ID: NCT05737017 Recruiting - Colonic Polyps Clinical Trials

The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet)

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

The ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure. In this study, the investigators examine the hemostatic effect of ClearCoajet on intraprocedural bleeding during endoscopic mucosal resection or endoscopic submucosal dissection for colorectal sessile polyps or lateral growth tumors larger than 1.5 cm. The investigators also aim to compare the delayed bleeding and recurrence rates between the ClearCoajet group and the control group.

NCT ID: NCT05732233 Terminated - Colon Adenoma Clinical Trials

RITUAL Ultivision AI CADe Randomized Controlled Trial

RITUAL
Start date: July 21, 2023
Phase: N/A
Study type: Interventional

Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas). Ultivision AI CADe is indicated for white light colonoscopy only.

NCT ID: NCT05730192 Recruiting - Colorectal Cancer Clinical Trials

EAGLE Trial CADDIE Artificial Intelligence Endoscopy

EAGLE
Start date: May 10, 2023
Phase: N/A
Study type: Interventional

The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected.

NCT ID: NCT05615857 Completed - Colorectal Cancer Clinical Trials

Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary

Start date: September 22, 2022
Phase: N/A
Study type: Interventional

The investigators hope that this project will determine if the Endocuff device is a useful adjunct during colonoscopy by optimizing polyp detection and eliminating the need for the painful rectal retroflexion. As such, by improving polyp detection and eliminating the need for rectal retroflexion, it will directly reduce the likelihood of colon cancer and improve patient comfort respectively.

NCT ID: NCT05611151 Recruiting - Colorectal Cancer Clinical Trials

Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy

COLOWISE
Start date: April 30, 2023
Phase: N/A
Study type: Interventional

This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC). Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy : - Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group) - Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)

NCT ID: NCT05559814 Completed - Colonic Polyp Clinical Trials

Intraluminal Peppermint Oil and Adenoma Detection Rate in Screening Colonoscopy

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

This is a prospective randomized placebo-controlled trial to evaluate the efficacy of peppermint oil spraying into the colonic lumen through the scope channel during screening colonoscopy. The primary outcome is to compare the colonic peristalsis between peppermint oil and placebo. The secondary outcomes compare the procedural time, polyp detection rate, adenoma detection rate, and adverse events.

NCT ID: NCT05517343 Recruiting - Depression Clinical Trials

Impact of Real-time Notification of Colonoscopic Optical Diagnosis on Patients' Anxiety and Depression After Polypectomy

Start date: August 20, 2022
Phase: N/A
Study type: Interventional

The accuracy of endoscopic optical diagnosis for colorectal polyps has been approaching histological diagnosis after implementation of image enhancement endoscopic technologies. The real-time notification of possible nature of resected polyp after colonoscopy is expected to reduce the anxiety and depression level of the patients before the availability of histological diagnosis and improve their quality of life. We designed and conducted a randomized control trial to confirm this hypothesis.