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Colorectal Polyp clinical trials

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NCT ID: NCT06032104 Recruiting - Obesity Clinical Trials

Feasibility and Colorectal Benefits of Pulses Supplementation

Start date: October 27, 2023
Phase: N/A
Study type: Interventional

Beans are a forgotten staple food that shows promise in improving health. The goal of this study is to look at how bean supplementation affects metabolic and bowel health. In the long-term, the investigators believe this research will lead to a better understanding of the impact of beans on bowel health. The investigators also hope that this research study will help us understand ways to improve human diet and prevent colon cancer in the future.

NCT ID: NCT05988645 Recruiting - Colorectal Cancer Clinical Trials

Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II)

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

The study involves the planned use of a new microwave-based device during colonoscopy procedures in 50 patients to assess the performance and safety of its use for detection of colorectal polyps and lack of normal clinical practice modification. The device is a final design version, which has been previously tested in several preclinical studies (including phantom studies, an ex vivo study with human tissues, and an in vivo study with porcine model) and in a pilot study in humans (NCT05477836)

NCT ID: NCT05877456 Enrolling by invitation - Colo-rectal Cancer Clinical Trials

Validation of the Global Polypectomy Assessment Tool (GPAT)

GPAT
Start date: March 1, 2023
Phase:
Study type: Observational

Colorectal polypectomy is offten incompletely performed with high variability between endoscopists, resulting in interval cancer or repeated procedures. Current available scoring systems for polypectomy technique are lacking in different areas so the investigators developed the Global Polypectomy Assessment Tool (GPAT) which is an online video-based assessment tool for any colorectal polypectomy. The goal of the study is to assess the validity of GPAT through demonstrating the inter-rater agreement (Fleiss Kappa (κ)). GPAT has 20 items, contains evidence-based statements to aid interpretation, calculates an overall quality score and a complexity score.

NCT ID: NCT05846295 Active, not recruiting - Colonic Neoplasms Clinical Trials

Online Education Module to Accurately Classify Polyp Size

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

Investigators developed an online educational module (ESTIMATE) to teach Gastroenterology (GI) trainees how to estimate polyp size using a snare. Key components include video instruction and real-time feedback incorporated over a 40-item polyp size assessment test. Trainees from GI fellowship programs will be randomized to one of four groups: control (no video, no feedback), video-only, feedback-only, and video + feedback. Participants will classify polyps into one of three size categories:- diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm). Primary outcome is accuracy of polyp size classification [diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm)]. Secondary outcomes include accuracy of exact polyp size (in mm), cumulative accuracy (to plot learning curves), confidence level of polyp size classification, and directionality of inaccuracy (polyp size overestimation vs underestimation).

NCT ID: NCT05825664 Recruiting - Clinical trials for Colorectal Neoplasms

Underwater Versus Conventional Endoscopic Mucosal Resection in the Treatment of Non-pedunculated Colorectal Polyps

Start date: April 7, 2023
Phase: N/A
Study type: Interventional

A prospective, randomized, controlled study to compare the efficacy and safety of underwater endoscopic mucosal resection and conventional endoscopic mucosal resection in removal of non-pedunculated colorectal polyps

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: NCT05734820 Recruiting - Colorectal Cancer Clinical Trials

Computer-aided Detection During Screening Colonoscopy

Start date: January 11, 2020
Phase: N/A
Study type: Interventional

Nowadays, colonoscopy is considered the gold standard for the detection of lesions in the colorectal mucosa. However, around 25% of polyps may be missed during the conventional colonoscopy. Based on this, new technological tools aimed to improve the quality of the procedures, diminishing the technical and operator-related factors associated with the missed lesions. These tools use artificial intelligence (AI), a computer system able to perform human tasks after a previous training process from a large dataset. The DiscoveryTM AI-assisted polyp detector (Pentax Medical, Hoya Group, Tokyo, Japan) is a newly developed detection system based on AI. It was designed to alert and direct the attention to potential mucosal lesions. According to its remarkable features, it may increase the polyp and adenoma detection rates (PDR and ADR, respectively) and decrease the adenoma miss rate (AMR). Based on the above, the investigators aim to assess the real-world effectiveness of the DiscoveryTM AI-assisted polyp detector system in clinical practice and compare the results between expert (seniors) and non-expert (juniors) endoscopists.

NCT ID: NCT05699954 Completed - Colorectal Cancer Clinical Trials

Assessment of the Blink (First) Impression Regarding the Presence of Cancer Within Colorectal Polyps

Start date: February 1, 2023
Phase:
Study type: Observational

Colorectal cancer (CRC) is a leading cause of death in the Western world. It can be effectively prevented by removal of pre-malignant polyps during colonoscopy. Large (≥20mm) non-pedunculated colorectal polyps (LNPCPs) represent 2-3% of colorectal polyps and require special attention prior to treatment. If submucosal invasive cancer (SMI) is suspected, careful decision making is required to exclude features which unacceptably increase the risk of lymph node metastases and render local treatment (endoscopic) non-curative. Such patients require a multi-disciplinary approach and consideration of surgery +/- systemic therapy. Unfortunately, current classification systems are complex, require extensive training and technology not available in the majority of non-tertiary hospitals. They are therefore underused leading to incorrect decision making and negative patient outcomes (e.g. piecemeal resection without the chance of endoscopic cure or unnecessary further procedures in referral centres with resultant surgery anyway or surgery for benign disease). Studies from the field of psychology show that humans are often capable of making correct decision based on their Blink (first) impression. It is also suggested that this Blink impression is based on experience and training. This might suggest that experienced or specialist endoscopist are better at diagnosing SMI within colorectal polyp at Blink impression. The investigators hypothesize that by training the Blink impression, endoscopist of varying experience are able to detect cancer within LNPCPs. This can be proven by assessing the Blink impression of endoscopist of varying experience regarding the presence of SMI within LNPCPs. Increasing the accuracy of the determination of SMI within colon polyps would directly translate into improvements in patient care and outcome. For example, if SMI is present and is not suspected, patients may undergo unnecessary endoscopic procedures for an LNPCP which will eventually require surgery anyway (inconvenience, delayed correct treatment). If the incorrect technique is performed in the context of superficial SMI, adequate assessment of complete excision or extent and type of SMI may not be possible and a patient who would otherwise have been cured may require surgery anyway (under-treatment, below standard of care outcome, delay to treatment). Conversely, if SMI is suspected in its absence patients may undergo unnecessary surgery, increased healthcare spends and mortality (over-treatment, unnecessary risk). If the presence of SMI could be accurately determined in real-time using endoscopic imaging, delays to treatment, over-treatment and the associated morbidity for patients could be avoided.

NCT ID: NCT05660317 Recruiting - Colorectal Polyp Clinical Trials

Assessment of Endoscopic Tip Control Using a Novel Score Based on the Snare Tip Soft Coagulation of Polypectomy Margin Defects

Start date: September 1, 2022
Phase:
Study type: Observational

Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer related death with approximately 880 792 deaths every year (9,2% of the global yearly 9.6 million cancer deaths). Screening for polyps is done by colonoscopy, which is considered the gold standard for screening and removal of polyps and has been proven to reduce the global colorectal cancer burden significantly. Endoscopic removal of polyps is preferred because of its efficiency, cost-effectiveness, and safety in comparison to surgery. Endoscopic tip control is a fundamental component of high quality endoscopy. Endoscopic procedures are complex processes where cognitive processing and motoric output need to be perfectly aligned. This is reflected in endoscopic tip control. It is indispensable in every step of endoscopy: during insertion of the endoscope, where the tip of the endoscope needs to reach the caecum/terminal ileum/duodenum, without discomfort for the patient if under light sedation, during withdrawal of the endoscope in order not to miss any lesions, and also during every endoscopic treatment whether it is a simple polypectomy or a complex therapeutic procedure performed by expert endoscopists. However, there is currently no tool available to assess endoscopic tip control. And very little is known about educating it. The investigators developed a new, web-based scoring system to assess tip control. The intent of this study is to validate this novel tool so it can be used to assess endoscopists and evaluate their progress when training in endoscopy. This study takes place at the University Hospital Ghent, which is a tertiary care center for gastrointestinal endoscopy. The investigators will validate the tool in this study, through assessment of endoscopists of varying experience while they use a technique of snare tip soft coagulation on the margin of a polypectomy defect. This technique has proven its use in preventing recurrence after polypectomy. The technique uses the tip of a snare (used to resect polyps) to deliver thermal energy to the margin of a polypectomy, also called margin ablation. Thermal energy is applied by a hit on a pedal (operated with the foot), every hit needs to be exactly on the margin of the defect (not in the defect, not on normal mucosa around the defect). This requires a very steady and controlled handling of the endoscope and is an ideal technique to assess endoscopist's tip control. The score system will calculate the accuracy (number of correct hits over number of wrong hits) of tip control per second.

NCT ID: NCT05636085 Not yet recruiting - Colorectal Cancer Clinical Trials

Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer and Advanced Adenoma

reconAAsense
Start date: June 1, 2023
Phase:
Study type: Observational

This study is to determine how the Mainz Biomed Colorectal Cancer Screening Test works when used in people aged ≥45 years of age and at an average risk of developing colorectal cancer.