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Polyp of Colon clinical trials

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NCT ID: NCT05829447 Completed - Polyp of Colon Clinical Trials

Combining Artificial Intelligence With Balloon Mucosal Exposure Device for Polyp Detection in Screening Individuals

COMBAT
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The present trial is aimed at evaluating whether in individuals scheduled for colonoscopy in the framework of a structured FIT (Fecal Immunochemical stool test)-based colorectal cancer screening program, the combination of an AI (artificial intelligence) system (CADEYE) with a mucosal exposure device (G-EYE 760R endoscope) increases the identification of subjects at high risk to develop colorectal cancer (according to recent ESGE-European Society of Gastrointestinal Endoscopy guidelines subjects are labelled as "high-risk" if harboring at least 1 adenoma ≥ 10 mm or with high grade dysplasia, or ≥ 5 adenomas, or any serrated polyp ≥ 10 mm or with dysplasia) when compared to colonoscopy performed with the support of AI only. Individuals fulfilling inclusion criteria are randomized (1:1) to two different arms (Control arm and Interventional arm, see below). Randomization is based on a computer-generated randomized block sequence, stratified according to age (50-61 vs. 62-74) and gender (male vs. female); size of the blocks (10 individuals) is not communicated to the investigator. Allocation is concealed and kept in a sealed envelope, which is opened just before starting colonoscopy. Individuals randomized in the Intervention arm receive colonoscopy examination with G-EYE 760R colonoscopes; once the cecum is reached the balloon is inflated, and the endoscope is withdrawn with the inflated balloon; the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination. Individuals randomized in the Control arm (CADEYE only) receive colonoscopy with G-EYE 760R colonoscope but the balloon remains deflated for the entire procedure; the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination. The main outcome measure is the rate of "high risk" individuals across the two study arms.

NCT ID: NCT05499546 Completed - Polyp of Colon Clinical Trials

Virtual Scale Function SCALE EYE: Variability and Systematic Differences

SCALE-EYE
Start date: October 11, 2022
Phase: N/A
Study type: Interventional

Size of colorectal polyps is important to decide on appropriate surveillance intervals and treatment modality, as well as carrying out optical diagnosis strategies. However, polyp size measurement is often prone to inter-observer variability. An easy and accurate tool to assist in polyp size measurement is required. Recently, a virtual scale function for size measurement during endoscopy (SCALE EYE), operating in real-time without the use of any additional devices, has been developed. The aim of this study is to assess whether use of the SCALE EYE for polyp size measurement can reduce inter-observer variability.

NCT ID: NCT05422820 Completed - Colorectal Cancer Clinical Trials

The Argentina Brief Colonoscopy Difficulty Score (ABCD)

ABCD
Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

Colonoscopy completion by caecal intubation seldom represents a significant effort for the endoscopist. In this situation, additional techniques are necessary to achieve this goal: patients' manual abdominal compression, postural changes, and endoscopist relay. To date, no tool allows colonoscopy technical difficulty grading. This study pursues to describe the frequency of additional techniques for caecal intubation in a large sample of Argentinians in different centres who undergo colonoscopy for attending purposes, to develop a novel score for assessing colonoscopy technical difficulty.

NCT ID: NCT05389397 Completed - Polyp of Colon Clinical Trials

De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas

DESIRE
Start date: May 12, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effectiveness of three standard of care outreach approaches (i.e., mailed letter, secure message, and telephone call) on patient adoption of the new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy. The primary study endpoint is the proportion of patients in each outreach arm who adopt the new 10-year colonoscopy surveillance interval.

NCT ID: NCT05178095 Completed - Clinical trials for Gastrointestinal Neoplasms

Artificial Intelligence in Colonic Polyp Detection

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.

NCT ID: NCT04925271 Completed - Fistula Clinical Trials

Closure of Mucosal and Submucosal Defects in the Gastrointestinal Tract Using the Novel X-Tack Endoscopic Suturing Device

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

After removing large polyps from the gastrointestinal tract, gastroenterologists close the new defect with devices to prevent complications like bleeding or the development of a leak. Commonly, this is done with a device called Overstitch, which allows the gastroenterologist to stitch the defect with an endoscope. A new device called X-tack has been developed to simplify endoscopic stitching. In this study, the new X-tack device will be compared to Overstitch when closing defects in the gastrointestinal tract. The two devices will be compared to see how long it takes to close a defect, as well as if there are any differences in complications like bleeding or infection.

NCT ID: NCT04924543 Completed - Ulcerative Colitis Clinical Trials

OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD

OPTIC-IBD
Start date: July 7, 2021
Phase: N/A
Study type: Interventional

People with inflammatory bowel diseases (IBD) can be at higher risk of developing abnormal areas in their bowel. These abnormal areas can be due to active inflammation, healed inflammation, polyps or pre-cancerous changes ("dysplasia"). It is for this reason that people with IBD are offered periodic surveillance colonoscopy procedures to identify, characterize and where necessary remove abnormal areas or lesions from the bowel. These can be difficult to characterize correctly, which is important to make the correct endoscopic diagnosis and management plan. Technical advancements in endoscopy mean that more tools are available to identify and characterize these lesions in real time during colonoscopy. Specialists regularly performing gastrointestinal endoscopy and colonoscopy ("endoscopists") will often receive special training, both during their initial postgraduate training and through continuous professional development programs. This study aims to evaluate whether an online training platform can improve the ability of endoscopists to characterize dysplasia in IBD. The goal is to support improved decision-making during IBD surveillance, reporting of dysplastic lesions, and ultimately the care and outcomes of people with IBD.

NCT ID: NCT04899700 Completed - Polyp of Colon Clinical Trials

Linked Color Imaging Versus White Light Endoscopy for the Evaluation of Scars of Non-pedunculated Polyps. LCI Scar Study.

LCIScar
Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Careful inspection and evaluation of the post-polipectomy scars of polyps greater than 20 mm looking for residual polyp is mandatory. LCI has demonstrated to improve polyp and adenoma detection rate in previous studies. However, to our knowledge no previous studies have been made for validation of LCI for optical diagnosis of a scar looking for residual neoplasia after a previous polypectomy. We hypothesize that LCI will improve the optical diagnosis of polyp recurrence compared to WLE. So, our aim is to compare the efficacy of linked color imaging for optical diagnosis of post-polypectomy scar recurrence compared with high-definition white light endoscopy.

NCT ID: NCT04691401 Completed - Polyp of Colon Clinical Trials

Impact of Artificial Intelligence (AI) on Adenoma Detection During Colonoscopy in FIT+ Patients.

AIFIT
Start date: December 20, 2020
Phase: N/A
Study type: Interventional

The Italian screening program invites the resident population aged 50-74 for Fecal Immunochemical Test (FIT) every 2 years. Subjects who test positive are referred for colonoscopy. Maximizing adenoma detection during colonoscopy is of paramount importance in the framework of an organized screening program, in which colonoscopy represent the key examination. Initial studies consistently show that Artificial iIntelligence-based systems support the endoscopist in evaluating colonoscopy images potentially increasing the identification of colonic polyps. However, the studies on AI and polyp detection performed so far are mostly focused on technical issues, are based on still images analysis or recorded video segments and includes patients with different indications for colonoscopy. At the best of our knowledge, data on the impact on AI system in adenoma detection in a FIT-based screening program are lacking. The present prospective randomized controlled trial is aimed at evaluating whether the use of an AI system increases the ADR (per patient analysis) and/or the mean number of adenomas per colonoscopy in FIT-positive subjects undergoing screening colonoscopy. Therefore Patients fulfilling the inclusion criteria are randomized (1:1) in two arms: A) patients receive standard colonoscopy (with high definition-HD endoscopes) with white light (WL) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination; B) patients receive colonoscopy examinations (with HD endoscopes) equipped with an AI system (in both insertion and withdrawal phase); all polyps identified are removed and sent for histopathology examination. In the present study histopathology represents the reference standard.

NCT ID: NCT04647266 Completed - Polyp of Colon Clinical Trials

Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions

Start date: June 16, 2016
Phase:
Study type: Observational

The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%. Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this. There is currently no score established for the colo-rectal endoscopic submucosal dissection. - To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital. - Allow to obtain an estimation of number of patients required for a larger study.