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Polyps clinical trials

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NCT ID: NCT03118856 Completed - Colorectal Polyp Clinical Trials

Electronic Chromoendoscopy for Polyp Characterization

Start date: February 1, 2017
Phase:
Study type: Observational

To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.

NCT ID: NCT03117114 Completed - Colon Polyp Clinical Trials

Endocuff Vision Assisted vs. Standard Polyp Resection in the Colorectum

EVASTA
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Adenomas are premalignant polyps of the colon that should be resected endoscopically. Complete resection of adenomatous polyps is the major task of colonoscopy. In some cases polyp may be poorly accessible making endoscopic resection difficult. Polypectomy may be conducted using the so-called piece meal technique in these cases. However, leaving polyp residual polyps in the colon bears the risk of malignant degeneration as colorectal cancer may arise form adenomatous remnants. In case of difficult polyp locations endoscopic resection may also be time consuming. On the other hand endoscopists are facing an increased time pressure due to rising numbers of procedures during the last decades. The Endocuff Vision device (EVD) is a cap that can be mounted to the tip of a standard endoscope. The EVD has small flexible branches on its outside. The branches turn out during withdrawal. By that the branches are getting in contact with colonic wall. This mechanism leads to a more stabilized position of the colonoscope in the bowel. It is hypothesized that resection circumstances may be improved by using an EVD. In addition, stabilizing the scope during resection may result in a reduced time effort. Until now no controlled trials exist investigating the effect of EVD on the time effect during polyp resection. Therefore a randomized controlled trial needed comparing standard polypectomy versus polypectomy using the EVD during routine colonoscopy procedures.

NCT ID: NCT03085797 Completed - Nasal Polyps Clinical Trials

Effect of Mepolizumab in Severe Bilateral Nasal Polyps

Start date: May 25, 2017
Phase: Phase 3
Study type: Interventional

Nasal polyps (NP) has long been known as chronic inflammatory disease of the nasal mucosa. This disease is characterized by the presence of polyps in the upper nasal cavity, originating from within the ostiomeatal complex. The presence of polyps can cause long-term symptoms such as prominent nasal obstruction, post-nasal drip, loss of smell, and discharge. Mepolizumab (SB240563) is an Immunoglobulin G 1 [IgG1], kappa humanized monoclonal antibody (mAB) that blocks human interleukin-5 (hIL-5) from binding to the interleukin-5 (IL-5) receptor complex expressed on the eosinophil cell surface and thus inhibits signaling. Neutralization of IL-5 with mepolizumab has been shown to reduce blood, sputum and tissue eosinophils and hence is assumed to be a treatment option in a number of eosinophilic diseases including NP. The aim of this randomized, double-blind, parallel group, phase 3 (PhIII) study is to assess the clinical efficacy and safety of 100 milligram (mg) subcutaneous (SC) mepolizumab as an add on to maintenance treatment in adults with severe bilateral NP. The study will include a 4-week run in period followed by randomization to a 52-week treatment period. Participants will receive mepolizumab 100 mg or placebo SC by the investigator or delegate via a pre-filled safety syringe every 4 weeks for 52 weeks. Throughout the entire study period (run in + treatment period + follow up), participants will receive a standard of care (SoC) for NP which consists of daily mometasone furorate (MF) nasal spray, and if required, saline nasal douching, occasional short courses of high dose oral corticosteroids (OCS) and/or antibiotics. The treatment period will consist of thirteen, 4-weekly doses of mepolizumab or placebo. In addition, up to the first 200 randomized participants will be followed up every other month for up to a further 6 months after the Visit 15 (7 months post last dose) in order to assess maintenance of response and to validate a physiological model derived from the previous Phase 2 study. Approximately 400 participants will be randomized (200 participants per treatment arm) in to the study. Total duration of the study will be 76 weeks for first 200 randomized participants and 52 weeks for remainder of participants who are not participating in the 6 months no treatment follow up.

NCT ID: NCT03073226 Completed - Barrett Esophagus Clinical Trials

A Prospective Study Comparing the Accuracy of Olympus Lucera Spectrum Technology vs Olympus Lucera Elite Technology in the in Vivo Diagnosis of Barrett's Oesophagus and Colorectal Polyps: The ELITE Study

ELITE
Start date: February 6, 2016
Phase: N/A
Study type: Interventional

Barrett's oesophagus is a condition where the lining of the oesophagus (gullet) wall changes. People with Barrett's oesophagus are at risk of developing oesophageal cancer but can have regular checkups to detect changes before they progress to cancer. Every two years patients with Barrett's are offered examination by passing a fibreoptic tube into the oesophagus (gastroscopy) to remove small tissue samples (biopsies), which are examined in the laboratory to check for changes. Bowel cancer is the third most common cancer in the UK, and the second leading cause of cancer deaths. Prevention and early detection are the most effective strategies of dealing with bowel cancer. Most cancers develop from benign polyps (growths) in the bowel. Polyps are common and have the potential of developing into cancer over the course of many years. Patients with a prior diagnosis of Barrett's oesophagus and colonic polyps undergo regular endoscopic examinations known as surveillance endoscopies. This is done to detect changes in the cells of Barrett's oesophagus or further polyps. Current practice is to capture recorded videos of Barrett's surveillance examinations and still images of polyps prior to their removal. Endoscope technology continues to advance. These newly developed technologies are marketed to have claims of superiority in performance over preceding generations often without the back up of scientific data but at a significant financial cost. The aim of this study is to use endoscopic images and videos recorded as part of routine clinical practice to compare the current version of Olympus endoscopes with the new version launched by the company.

NCT ID: NCT03072472 Completed - Clinical trials for Colorectal Neoplasms

BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

B-ADENOMA
Start date: February 14, 2017
Phase: N/A
Study type: Interventional

This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.

NCT ID: NCT03065868 Completed - Clinical trials for Helicobacter Pylori Infection

Effect of H. Pylori Eradication on the Fate of H. Pylori-associated Gastric Polyp

Start date: December 9, 2015
Phase: Phase 4
Study type: Interventional

Evaluation of the effect of H. pylori eradication on regression of H. pylori-related gastric polyp (Ranomized controlled trial) 1. Study design: open labeled RCT 2. Study group H. pylori eradication group (N=17), non-eradication group (N=15) 3. Treatment plan 1. Baseline EGD : 0.3-1cm sized polyp - bx & CLO test (antrum & body) ==> if H. pylori positive and eligible patients, randomization 2. Triple therapy 3. UBT (4week after eradication) 4. Follow-up EGD: gross finding, CLO test 4. Evaluation of polyp regression 1. disappear 2. regression over 50% (size, number) 3. no change or increase (size, number)

NCT ID: NCT02986308 Completed - Intestinal Polyps Clinical Trials

The Metabolomics of Intestinal Polyps of Different Pathological Types and TCM Syndromes and TCM Constitution Types

Start date: June 13, 2016
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to confirm the TCM syndrome types and TCM constitution classifications of the patients with intestinal polyps via on-site epidemiological survey, to analyze metabolomics of the serum samples of intestinal polyps and healthy volunteers, and to study the metabolomics differences of the two populations and the metabolomics variations of the patients with intestinal polyps of pre-polypectomy and post-polypectomy. Finally, this study is to investigate the serum metabolomics variations of patients with intestinal polyps of pre-polypectomy and post-polypectomy and the relationship with their TCM syndrome types and TCM constitution classifications, to determine the correlation among pathology, TCM constitution, TCM syndrome types and the metabonomics variations of patients with intestinal polyps.

NCT ID: NCT02937506 Completed - Colon Cancer Clinical Trials

Patient Satisfaction With Propofol for Out Patient Colonoscopy

Start date: November 2013
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.

NCT ID: NCT02912468 Completed - Clinical trials for Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

SINUS-24
Start date: December 5, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was a coprimary objective. Secondary Objectives: - To evaluate the efficacy of dupilumab in improving total symptoms score (TSS). - To evaluate the efficacy of dupilumab in improving sense of smell. - To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japan). - To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery. - To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22). - To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated respiratory disease [ERD]). - To evaluate residual effect in follow up. - To evaluate the safety of dupilumab in participants with bilateral NP. - To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment-emergent anti-drug antibodies.

NCT ID: NCT02898454 Completed - Clinical trials for Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

SINUS-52
Start date: November 28, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab 300 mg every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion (NC)/obstruction severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyps (NP). In addition for Japanese participants, reduction in computed tomography (CT) scan opacification of the sinuses was a co-primary objective. Secondary Objectives: - To evaluate the efficacy of dupilumab in improving total symptoms score. - To evaluate the efficacy of dupilumab in improving sense of smell. - To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japanese participants). - To evaluate ability of dupilumab in reducing proportion of participants who required treatment with systemic corticosteroids (SCS) or surgery for NP. - To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life. - To evaluate the efficacy of dupilumab 300 mg q2w up to Week 52. - To evaluate the efficacy of dupilumab 300 mg q2w up to Week 24 followed by 300 mg every 4 weeks (q4w) up to Week 52. - To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and comorbid asthma including non-steroid anti-inflammatory drug exacerbated respiratory disease. - To evaluate the safety of dupilumab in participants with bilateral NP. - To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment emergent anti-drug antibodies.