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Polyps clinical trials

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NCT ID: NCT03000868 Withdrawn - Colonic Polyps Clinical Trials

Comparison of Small Colorectal Polyp Removal Using Cold EMR With Hot EMR

Start date: December 1, 2016
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of small colorectal polyp removal using cold endoscopic mucosal resection with hot endoscopic mucosal resection. Half of the participants will receive cold endoscopic mucosal resection, while the other half will receive hot endoscopic mucosal resection.

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: NCT02975310 Recruiting - Sinusitis Clinical Trials

In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps

Start date: April 11, 2017
Phase: N/A
Study type: Interventional

Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and headache, an inability to breath through the nose and complete smell loss, regularly impair one's ability to work and to enjoy and participate in daily activities. The annual cost of chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with polyps, the most common type of chronic sinusitis, is usually treated with a combination of medications and surgery. Until now, surgical treatment has only been performed in the operating room, at a cost of about $3500 per procedure. But, recent studies have shown that a new procedure, "in-clinic polyp removal", can provide an improvement in patient symptoms to levels equal to those for sinus surgery performed in a hospital operating room. Moreover, in clinic polyp removal has additional advantages including a shorter procedure recovery time, a significantly lower cost to the health care system (about one-tenth the cost or $450), and a shorter wait time for treatment. With the proposed pragmatic trial, the investigators will determine whether the in clinic polyp removal procedure is as good as sinus surgery in the operating room at controlling patient symptoms of chronic sinusitis. The investigators will also determine the cost and health-benefits for a patient, the healthcare system and for society of in clinic polyp removal in comparison to sinus surgery done in a hospital operating room. The investigators will then know if this new treatment, in clinic polyp removal, can replace sinus surgery as the standard of care for these patients.

NCT ID: NCT02970760 Not yet recruiting - Colonic Polyp Clinical Trials

Computer Assisted Measurement of Colorectal Polyps

Start date: December 2016
Phase: N/A
Study type: Observational

Adenomas are polyps of the colorectum that have the potential to develop into colon cancer. However, some adenomas never become malignant tumors, or if so, progression from adenoma into cancer takes a long time. As a result, screening colonoscopy programs were established in order to detect and resect adenomas at an early stage. After resection, polyps should be sent to pathology in order to make a histological diagnosis. Approximately 40-50% of all polyps have adenomatous histology whereas others contain benign histology (e.g. hyperplastic or inflammatory polyps). The latter polyps do not bear the risk to develop colon cancer. The bigger a polyp is the greater the chance is of it being malignant. During colonoscopy polyp size can be estimated visually by comparing the polyp with an opened biopsy forceps. The span of an opened forceps is 7 mm. Prior to using this technique, the forceps has to be inserted into the colon through a small working channel of the endoscope. Information on the actual adenoma size is crucial as surveillance recommendations depend on the size of the resected polyps. Moreover current guidelines contain the possibilities to disregard hyperplastic polyps in the sigmoid colon if the polyp size is below 5 mm. This means that diminutive hyperplastic polyps (< 5mm) do not necessarily require resection due to their benign dignity. However, there is increasing evidence that large human bias effects exist in estimating the size of polypoid lesions. For example, it has been shown that endoscopists exhibit terminal digit preferences leading to an exaggeration of estimated polyp size. In consequence the human bias problem might lead to wrong adenoma surveillance decisions. There is no doubt that technical devices are needed which can support endoscopists in finding the right declaration of polyp sizes. The aim of the current project is to create a computer program that is able to automatically measure polyp sizes during colonoscopy.

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: NCT02929641 Recruiting - Colorectal Polyps Clinical Trials

Evalution of Optical Enhancement With Magnification for Polyop Histology

Start date: August 2016
Phase: N/A
Study type: Observational

When a polyp is found, it woulf be recorded by a white-light and OE1 model with magnification for assessing and predicting its histology. After that, its really histology will be reported by an pathologist. When a polyp is found, OE mode 1 with magnification was first used with near focus the polyp and an endoscopist made a real-time prediction of polyp pathology. After that, high-definition mode and OE mode 1 without magnification were used to observe polyp sequencely. The video of all procedure was recorded.

NCT ID: NCT02929381 Recruiting - Neoplasms Clinical Trials

Advanced Endoscopic Imaging in Colonoscopy

AEI
Start date: June 2016
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical practice. The important elements of this evaluation are: - Evaluation of the character of neoplastic lesions in the colon based on different imaging techniques - Verification of the endoscopic image with histopathologic descriptions - Establishing the type of the lesion on the basis of Kudo and NICE classifications - Comparison of the result of histopathological examination with the macroscopic type of the lesion - Determination of the most advanced lesions (MAL) - Comparison of the cecal intubation time - Evaluation of the type of anesthesia used during colonoscopy - Subjective assessment of the severity of pain according to VAS (visual analogue scale) - Comparison of the accuracy of the location of lesions on the basis of endoscopic navigation - Comparison of the total examination time - Comparison of adenoma detection rate

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.

NCT ID: NCT02855931 Completed - Sinusitis Clinical Trials

Study to Compare Resection Versus Preservation of the Middle Turbinate in Surgery for Nasal Polyps

Start date: April 2016
Phase: N/A
Study type: Interventional

Endoscopic sinus surgery (ESS) has become the standard of care for patients suffering of chronic rhinosinusitis with nasal polyposis (CRSwP) who have failed medical therapy. The goal of surgery is now to widely marsupialize the sinus cavities in order to optimize topical steroid irrigation treatment in the postoperative period. With that being said, the true extent of surgery needed for optimal patient outcome has yet to be elucidated. More specifically, in the last 30 years, people have argued about the best way to manage the middle turbinate. Some state that it should be preserved at all times to protect the sinus cavities from inhaled irritants and allergens and keep this surgical landmark untouched for future surgeries. On the other hand, there are defenders of routine resection of this turbinate, whether it is affected by polypoid changes or not. Many studies have looked at the potential risks of resecting the middle turbinates such as iatrogenic frontal sinusitis, anosmia, or atrophic rhinitis but the more recent literature does not show such significant associations. A recent topic of debate is whether partial removal of the anterior and inferior portion of the middle turbinate affects nasal polyps recurrence or improves long-term outcomes by further facilitation of post-operative topical therapies. Some retrospective data has shown that its resection could prolong the time before the need for revision surgery and improve both endoscopic and olfaction scores. A few prospective studies have also been published but unfortunately none of these were randomized, thus introducing a significant selection bias. Thus, there is a need for a formal randomized, controlled trial to elucidate this question.