72 Clinical Trials for Various Conditions
This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC). Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy : * Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group) * Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)
This phase II trial studies how well nivolumab works in preventing colon adenomas in participants with Lynch syndrome and a history of surgery to remove part of the colon. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.
The goal of this study is to compare two FDA approved distal colonoscope attachment devices, in order to identify which device can increase adenoma detection rate the most without increasing procedure time or risk.
This will be a retrospective chart review of 880-1000 patients who had a colonoscopy and were found to have a tubular adenoma between the years of 2004-2008. We will compare the rate and timing of completion of repeat colonoscopies pre and post establishment of a polyp registry (tracking system) in 2006. Each group will be composed of up to 500 subjects consecutively identified from all the patients who underwent colonoscopy and were found to have a tubular adenoma (Group 1-2004 to 2006, Group 2 2007-2008).
Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas). Ultivision AI CADe is indicated for white light colonoscopy only.
Water exchange (WE) is an effective insertion method to minimize insertion discomfort and maximize ADR. It is characterized by infusing water to guide insertion in an airless lumen with suctioning of infused water during insertion and almost complete removal of the infused water when cecal intubation is achieved. A modified Delphi review reported water exchange showed the highest overall ADR, ADR in screening cases, and in the right side of the colon compared with water immersion and air (or CO2) insufflation. One of the plausible mechanisms of improving ADR by water exchange is salvage cleaning during insertion, which might help artificial intelligence by removing the interference of fecal debris and bubbles. However, no RCT has been performed to evaluate the effect of CADe on WE colonoscopy. Therefore, investigators will conduct a RCT comparing the ADR of CADe assisted colonoscopy inserted with either WE or insufflation. Our hypothesis will be that CADe assisted WE colonoscopy achieves higher ADR than CADe assisted air insufflation colonoscopy.
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.
The purpose of this observational study is to record performance of a double balloon endolumenal interventional platform during complex colon polypectomy.
The goal of this study is to compare the adenoma detection rate achieved while using either a 24" video monitor or a 32" video monitor.
The study will compare the use of cold snare piecemeal resection (CSPR) vs cold endoscopic mucosal resection (Cold EMR). The study will include two cohorts: one cohort for conventional adenomas 10-19mm in size and one cohort for serrated lesions 10mm or larger.
This study is aiming to enroll 90 patients with genetically confirmed Lynch Syndrome (LS) from Geisinger's High Risk Colorectal Cancer Clinic (HRC). Upon enrollment in the study, a Cologuard test will be ordered and the results will be blinded until data analysis. Patients enrolled in the study will also undergo a colonoscopy as part of their routine HRC visit.
EndoVigilant software device augments existing colonoscopy procedure video in real-time by highlighting colon polyps and mucosal abnormalities. It is intended to assist gastroenterologists in detection of adenomas and serrated polyps. The device is an adjunctive tool and is not intended to replace physicians' decision making related to detection, diagnosis or treatment. This study with an adaptive design measures the clinical benefit (increase in detection of adenomatous and serrated polyps) and increased risk (increased extraction of non-adenomas) during standard colonoscopy procedures when EndoVigilant software device is used.
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR. In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
The study will compare the use of cold snare, hot snare, cold EMR, and hot EMR for polyp resection. Although previous studies have compared two of the potential resection methods, no previous study has evaluated all four of the resection methods.
The purpose of this study to evaluate and examine whether use of Hybrid Argon Plasma Coagulation (APC) as an adjunct to endoscopic mucosal resection (EMR) will reduce the risk of residual or recurrent neoplasia at 6 months. Hybrid APC is an existing FDA approved device used to assist with ablation of abnormal tissue anywhere in the GI tract.
When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. The cancer cells may shed this DNA into the blood stream. This circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory tests. Measurement of ctDNA has been shown to be useful for following patients with known cancer. It has also been found in the circulation of some patients with early stage cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in individuals without known cancer who are scheduled to undergo a screening or diagnostic colonoscopy in order to see if the ctDNA test can detect a cancer or precancerous condition at a very early stage before the patient becomes symptomatic. The results of this study should help define the role of ctDNA in the detection of early stage colon cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctDNA found in patients with benign diseases or no abnormalities).
Colon cancer is the third most common cancer in western society. To prevent colon cancer it is recommended for people to undergo a screening colonoscopy at the age of fifty. The purpose of the colonoscopy is to remove polyps, since some of these lesions are precancerous. Precancerous polyps are called adenomas. This method of prevention is effective, but the standard colonoscopy currently used does not detect all polyps. Studies have reported a polyp miss rate of about 24%. Furthermore, we are unable to distinguish precancerous polyps from benign polyps, also known as hyperplastic polyps, with standard colonoscopy. This results in all polyps being removed at time of colonoscopy, even the benign polyps. To help improve the detection of colon polyps new endoscopic technologies have been developed. These technologies include high definition white light (HDWL)and high definition narrow band imaging (HDNBI). HDWL improves the overall resolution of the images seen during colonoscopy. HDNBI can help us better classify polyps by enhancing their tissue appearance as well as seeing small blood vessels and capillaries. The goal of this study to determine if HDNBI imaging shows an increased polyp detection rate when compared to the current standard colonoscopy. In addition to develop a classification system to help better differentiate between precancerous polyps and their benign counterparts using HDWL and HDNBI.
Non-inferiority trial comparing the recurrence rate of adenomas in non-pedunculated colonic lesions following endoscopic mucosal resection with margin marking (EMR-MM) and endoscopic mucosal resection with thermal margin ablation (EMR-STSC)
This study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times.
The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.
This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. * The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. * The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.
Adenoma detection rate (ADR) is a validated quality metric for colonoscopy with higher ADR correlated with improved colorectal cancer outcomes. Artificial intelligence (AI) can automatically detect polyps on the video monitor which may allow endoscopists in training to improve their ADR. Objective and Purpose of the study: Measure the effect of AI in a prospective, randomized manner to determine its impact on ADR of Gastroenterology trainees.
This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.
Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this study is to develop and validate a blood-based assay to detect colorectal cancer by collecting blood and stool samples from healthy patients undergoing routine screening colonoscopy and from patients recently diagnosed with colorectal cancer or advanced adenomas.
The PeerScope System consists of Peer Medical camera heads, endoscopes, video system, light source and other ancillary equipment. The system is intended for endoscopic diagnosis, treatment and video observation of the digestive tract. The PeerScope system model B is indicated for use for endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients. Objective:To compare the additional diagnostic yield obtained by using the PeerScope System™ extended view vs. the diagnostic yield obtained by the Standard view colonoscopy. In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.
The aim of this study is to develop a blood test to determine which patients are at risk for pre-cancerous colon polyps (ACPs: Advanced Colon Polyps). The telomere length of peripheral blood lymphocytes (PBLs) can be measured from a blood sample. Mechanistic pathways and the investigator's preliminary data support PBL telomere length as a biomarker for ACPs. The long-term goal of this project is to decrease deaths from colon cancer by using a blood test to target colonoscopy for those patients who are at high risk for pre-cancerous polyps.
The Mainz Biomed Colorectal Cancer Screening Test is being studied for its performance in the identification of the presence of colorectal cancer (CRC) or advanced adenoma (AA) in the colon in patients at average risk for colorectal cancer.
This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.
The purpose of this study is to compare the effectiveness of three standard of care outreach approaches (i.e., mailed letter, secure message, and telephone call) on patient adoption of the new 10-year colonoscopy surveillance interval recommendation for a random sample of health plan members who have a now-outdated 5-year surveillance interval due to a finding of 1-2 small adenomas at their prior colonoscopy. The primary study endpoint is the proportion of patients in each outreach arm who adopt the new 10-year colonoscopy surveillance interval.
This is a multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy