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Polyps clinical trials

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NCT ID: NCT05275556 Completed - Colon Polyp Clinical Trials

Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study)

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

This is a prospective, multicenter, randomized controlled study to evaluate the effect of the Computer-Assisted Detection (CADe) Device on Adenomas Per Colonoscopy and Positive Percent Agreement for routine colonoscopies. The control arm is colonoscopy performed with High Definition White Light Endoscopy (HD-WLE) per standard of care. The intervention arm is colonoscopy performed with HD-WLE per standard of care plus the Computer-Assisted Detection (CADe) Device.

NCT ID: NCT05274750 Active, not recruiting - Nasal Polyps Clinical Trials

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

ANCHOR-1
Start date: April 22, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with CRSwNP.

NCT ID: NCT05273697 Completed - Colon Polyps Clinical Trials

Clinical Study to Compare Cold Snare Underwater Polypectomy to Cold Snare Conventional Polypectomy for Colon Polyps [COLDWATER Study]

COLDWATER
Start date: March 21, 2022
Phase: N/A
Study type: Interventional

Colon cancer is internationally the third cause of deaths from a malignant disease. Screening colonoscopy in adults >45 years of age aims at the early diagnosis and treatment colon polyps that are precancerous lesions. Endoscopic polyp removal (polypectomy) can be done with various techniques depending on the size, morphology, location of the polyp etc. According to updated guidelines, non-pedunculated polyps of small size are treated with a cold snare in air dilated intestinal lumen (conventional cold snare polypectomy - CCSP).In recent years, several studies have described the benefits of water aided colonoscopy, as well as safety and efficacy of underwater polypectomy in large colon polyps. However, there is not enough data on small polyps which are the most commonly diagnosed.This is a prospective randomized double-blind clinical trial to compare the safety and efficacy of CCSP to underwater cold snare polypectomy (UCSP)for non-pedunculated polyps of size of 5-10 mm. A total of 398 polyps will be randomized and randomization will be performed via random numbers method of Microsoft Excel 2016. Primary outcome of this study is to determine muscularis mucosa resection rate. Secondary outcomes are the depth and percentage of R0 excisions and possible complications. The investigators expect UCSP to ensure a higher muscularis mucosa resection rate and they attempt to examine the resection depth in the submucosal layer.These results will provide useful data for the development of guidelines in polypectomy techniques for non-pedunculated polyps 5-10mm.

NCT ID: NCT05248997 Completed - Clinical trials for Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

Start date: February 17, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of chronic rhinosinusitis (CRS) with and without nasal polyps.

NCT ID: NCT05236790 Completed - Colorectal Adenoma Clinical Trials

Evaluation of CAD-EYE/SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study

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

The investigators hypothesize that the clinical implementation of an AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps during colonoscopy. The purpose of this prospective clinical cohort study is to evaluate the performance of the SCALE-EYE virtual scale for measuring polyp size when used during live colonoscopies. The investigators also wish to evaluate CAD-eye for detection and classification of polyp histology. It is hypothesized that CAD-eye and SCALE-EYE can function in real-time practice with high accuracy.

NCT ID: NCT05228041 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

BIOlogics in Severe Nasal POlyposis SurvEy

BIOPOSE
Start date: February 10, 2022
Phase:
Study type: Observational

With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed. During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production. New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies. Herein we propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.

NCT ID: NCT05220345 Recruiting - Colonoscopy Clinical Trials

Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With CADe (Discovery System) on Adenoma Detection Rate.

DiscoveryIII
Start date: March 31, 2022
Phase: N/A
Study type: Interventional

Colonoscopy is the gold standard for colorectal screening. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colon during the procedure. To increase detection new polyp detection systems based on artificial intelligence (AI) have been developed. However, these systems still depend on the ability of the endoscopist to adequately visualize the complete colonic mucosa, especially to detect smaller and more subtle lesions, or lesions hidden behind folds in the colon. With this study we want to combine a device to flatten the folds in the colon combined with an artificial intelligence system to further improve the detection rate of lesions during colonoscopy.

NCT ID: NCT05191095 Completed - Colorectal Polyp Clinical Trials

The Accuracy of Human Endoscopic Detection of Submucosal Invasive Cancer in Colorectal Polyps

Start date: March 1, 2021
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 (polypectomy) during colonoscopy. Large (≥20mm) non-pedunculated colorectal polyps (LNPCPs) represent 2-3% of colorectal polyps, and require special attention prior to treatment. If submucosal invasion (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. Recently the endoscopic imaging characteristics which precisely determine the risk of SMI within colon polyps have been elucidated. This suggests endoscopic imaging may be the ideal investigation to stratify the presence and extent of SMI within LNPCP, particularly as it can be applied in real-time at the time of planned endoscopic treatment. 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 outcome (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) A simple clinical support tool was created, based on well-established parameters (i.e., presence of a demarcated area within a polyp, size of the polyp, Paris classification, location within the colon and granularity) to identify OVERT (visible on the surface) and COVERT (hidden) submucosal invasion (SMI) within LNPCPs. Crucially this tool only uses what is reproducible in the majority of endoscopy units in the Western world (i.e. standard magnification, no extra chromic dyes etc). predict SMI within LNPCPs and we translated it into a single web-based clinical support tool that can be used by every endoscopist (expert and non-expert). To evaluate the tool, a survey will be send to participants. The survey consist of a 10-minute educational video where the use of the tool will be explained. Then 20 standardised videos of LNPCPs will be shown. Participants are first asked about their first impression regarding the presence of SMI. Then they are redirected to the web-based tool. After filling the required data from a standardised video (45 seconds to minute, no focus on one particular area of the polyp) the score generated by our tool is copied to the participants computer clipboard and then pasted in the survey so that we could analyse it.

NCT ID: NCT05189912 Completed - Colonic Polyp Clinical Trials

Clinical Study on the Application of a Specimen Retrieving Bag to Reduce the Polyp Fragmentation Rate

Start date: January 17, 2022
Phase: N/A
Study type: Interventional

It is necessary to retrieve the resected polyp to determine the pathological nature of polyp and to judge the completeness of resection in polypectomy. For polyps with a larger diameter (>5mm), the most reliable way to retrieve them is to suck them out with the colonoscope. However, this method requires multiple colonoscope insertions, resulting in prolonged operation time and increased patient suffering. Therefore, clinicians often receive polyps by pressing the colonoscope suction valve. But it is difficult to receive polyps or even fail to receive. Even if the polyps were successfully received by this method, many polyps were fragmented. When the polyp is fragmented, the pathologist cannot be sure of the completeness of the polyp removal. By removing the colonoscope suction valve and connecting a polyp trap to suction onto the instrument channel port, the polyp fragmentation rate was reduced greatly. To further reduce the polyp fragmentation rate, while reducing the operation time and colon insertions, we applied the polyp receiving bag in colonoscopy operations. The primary purpose of this study is to evaluate the effectiveness of the application of the polyp retrieving bag to reduce the polyp fragmentation rate.

NCT ID: NCT05180357 Completed - Nasal Polyps Clinical Trials

RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.

RANS
Start date: November 23, 2021
Phase:
Study type: Observational

The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.