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Polyps clinical trials

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NCT ID: NCT05179837 Active, not recruiting - Rectal Cancer Clinical Trials

Endoscopic Optical Coherence Tomography for Screening and Diagnosis of Colorectal Precancerous and Malignant Polyps

Start date: January 24, 2022
Phase: N/A
Study type: Interventional

Colorectal cancer arises from the mucosal layer of the colon. Current screening is performed by flexible endoscopy, which involves visual inspection of the mucosal lining of the colon and rectum with an optical camera mounted on the endoscope, with abnormal areas being biopsied. This method is somewhat limited in that there are no readily available surface pattern or morphological classification systems with adequate sensitivity or specificity to evaluate extent of submucosal invasion (deep, superficial, or none). Optical coherence tomography (OCT) using pattern recognition is a high-resolution imaging modality. There is currently an unmet need to predict depth of invasion for colonic tumors to decide on applicability of endoscopic (endoscopic submucosal dissection or endoscopic mucosal resection) vs. surgical therapy. The investigators' hypothesis is that OCT will have a higher diagnostic accuracy for determining depth of submucosal invasion compared to existing modalities. The investigators will first aim to assess the procedural feasibility and safety of using an OCT probe during routine colonoscopy with an early feasibility study. This study will identify appropriate modifications to the device and help with development of subsequent clinical study protocols. The eventual goal is to assess the diagnostic accuracy of OCT imaging for predicting depth of invasion of colonic tumors.

NCT ID: NCT05143502 Active, not recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.

Start date: January 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the work is to examine the efficacy of montelukast as an adjunct to steroid therapy in patients with chronic rhinosinusitis with nasal polyps.

NCT ID: NCT04998604 Active, not recruiting - Asthma Clinical Trials

EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients

EVEREST
Start date: September 27, 2021
Phase: Phase 4
Study type: Interventional

Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives - To evaluate the efficacy of dupilumab in improving CRSwNP symptoms at Week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving lung function at Week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on asthma control at Week 24 compared to omalizumab - To evaluate the safety of dupilumab and omalizumab

NCT ID: NCT04889352 Active, not recruiting - Colo-rectal Cancer Clinical Trials

Optimizing Timing of Follow-up Colonoscopy

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Overall Objective: To optimize timing of surveillance colonoscopy. Principal research question and specific aims: To assess the impact of access to a hand-held application on the timing of surveillance colonoscopy. To assess whether access to the tool improves adherence to recommended guidelines for follow-up colonoscopy intervals. Colonoscopy is commonly used for surveillance of patients with high risk of developing colorectal cancer, including those with family history of colorectal cancer and those with colorectal polyps. The recommended timing of surveillance colonoscopy varies by the estimated risk for development of colorectal cancer. The estimated risk varies by family history of colorectal cancer (number of affected individuals, age of the persons affected with CRC) and characteristics of the colorectal polyps (size, number, and histology of colorectal polyps (tubular or villous; high grade or low-grade dysplasia; sessile serrated polyp, sessile serrated polyp with dysplasia, hyperplastic polyp or traditional serrated adenomas). Guidelines take all of these factors into account in the recommendations for follow-up colonoscopy and hence are difficult to recall for the busy clinicians. Colonoscopy surveillance is frequently performed at shorter or longer than the recommended time intervals. The investigators have developed a smart phone application in which the characteristics of the patients can be inputted and the tool provides the recommended time interval for surveillance colonoscopy, based on North American guidelines. The investigators are proposing a pilot randomized trial to determine sample size estimates for a larger trial to assess the utility of this application in clinical practice.

NCT ID: NCT04727814 Active, not recruiting - Colon Polyp Clinical Trials

Comparison of Polyp Detection and False Alarm Rates in Water Exchange and Air Insufflation Colonoscopy

Start date: August 1, 2020
Phase:
Study type: Observational

Water exchange (WE) improves adenoma detection rate (ADR) but missed polyps occur due to human limitations. Computer-aided detection (CADe) improves polyp detection and can overcome human omissions, but a limiting factor is feces and air bubbles related false alarms (FA). WE provides salvage cleansing and can potentially reduce FA. The investigators compared the additional polyp detection rate (APDR) and false alarm rate (FAR) by CADe between WE and air insufflation.

NCT ID: NCT04451512 Active, not recruiting - Clinical trials for Colonic Polyps/Colonoscopy/Colorectal Neoplasms

Comparison of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.

Start date: January 1, 2020
Phase:
Study type: Observational

Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or hot snare were included in the study, signed by endoscopic treatment written informed consent for surgery, patients with detailed tracking and record the basic information and information related to the operation, postoperative lack of region and edge endoscopic observation carefully no residue, additional excision may be took if necessary,after resection specimen inspection, and in 6 months review colonoscopy, assess whether there is residual or recurrence of polyps.Main outcome: technical success rate (no other auxiliary resection), complete resection rate, secondary outcome: intraoperative and postoperative complications, polypectomy time and related costs, influential factors of incomplete resection.Research significance: The effectiveness, safety and cost-effectiveness of cold and hot snare resection of 10-19mm colorectal polyps were compared, and the influencing factors of incomplete polyps resection were analyzed, so as to provide evidence for the decision on the best method of medium-size polyps resection.

NCT ID: NCT04369053 Active, not recruiting - Colorectal Cancer Clinical Trials

Prevention of Colorectal Cancer Through Multiomics Blood Testing

PREEMPT CRC
Start date: May 20, 2020
Phase:
Study type: Observational

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

NCT ID: NCT04339855 Active, not recruiting - Clinical trials for Focus of the Study is to Evaluate a New Developed Deep-learning Computer-aided Detection System in Combination With LCI for Colorectal Polyp Detection

AI for Colorectal Polyp Detection in Endoscopy

Start date: February 1, 2019
Phase:
Study type: Observational

Linked color imaging (LCI) has shown its effectiveness in multiple randomized controlled trials for enhanced colorectal polyp detection. Most recently, artificial intelligence (AI) with deep learning through convolutional neural networks has dramatically improved and is increasingly recognized as a promising new technique enhancing colorectal polyp detection. Study aim was to evaluate a new developed deep-learning computer-aided detection (CAD) system in combination with LCI for colorectal polyp detection.

NCT ID: NCT04325815 Active, not recruiting - Colorectal Polyp Clinical Trials

CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

CADDIE
Start date: April 29, 2021
Phase:
Study type: Observational

Background: Colonoscopy is accepted to be the gold standard for screening of colorectal cancer (CRC). Most CRCs develop from adenomatous polyps, with colonoscopy accepted to be the gold standard for screening of CRC. An endoscopist's ability to detect polyps is assessed in the form of an Adenoma Detection Rate (ADR). Each 1.0% increase in ADR is associated with a 3.0% decrease in the risk of the patient developing an interval CRC. There remains a wide variation in endoscopist ADR. More recently, the use of artificial intelligence (AI) and computer aided diagnosis in endoscopy has been gaining increasing attention for its role in automated lesion detection and characterisation. AI can potentially improve ADR, but previous AI related work has largely focused on retrospectively assessing still endoscopic images and selected video sequences which may be subject to bias and lack clinical utility. There are only limited clinical studies evaluating the effect of AI in improving ADR. The CADDIE device uses convolutional neural networks developed for computer assisted detection and computer assisted diagnosis of polyps. Primary objective: To determine whether the CADDIE artificial intelligence system improves endoscopic detection of adenomas during colonoscopy. Primary endpoint: The difference in adenoma detection rate (ADR) between the intervention (supported with the CADDIE system) and non-intervention arm Study design: Multi-Centre, open-label, randomised, prospective trial to assess efficacy and safety of the CADDIE artificial intelligence system for improving endoscopic detection of colonic polyps in real-time.

NCT ID: NCT03943121 Active, not recruiting - Sinusitis Clinical Trials

The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Start date: October 8, 2018
Phase: N/A
Study type: Interventional

The treatment of eosinophilic sinusitis with nasal polyps is difficult and challenging. After endoscopic sinus surgery(ESS), complications such as edema, scar formation, adhesions, sinus stenosis and recurrence of polyps are prone to occur. Investigators aim to assess the efficacy and safety of Steroid-eluting stent when implanted in sinus in patients following ESS with eosinophilic sinusitis and nasal polyps.The randomized, double-blind, controlled clinical trial enrolled patients with eosinophilic sinusitis and nasal polyps. After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus and the other side as a control. Primary outcomes are change in the Lund-Kennedy endoscopic score.The primary outcomes will be measured in baseline, week4,week 8 and week 12. Secondary outcomes include the changes in symptoms measured by Visual analog score and nasal patency (nasal airway resistance and nasal cavity volume), exhaled nasal nitric oxide. The investigators also evaluate change in inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor-β, Leukotriene,Eotaxin) in nasal secretions. The secondary outcomes will be measured in baseline, week4, week8 and week12. Mucosal pathology assessment will be performed at 4 weeks postoperatively.Sinus CT scan will be conducted at 8 weeks after surgery. Changes in serum cortisol are monitored at baseline,week4 and week12 postoperatively. All adverse events are recorded throughout the experiment