56 Clinical Trials for Various Conditions
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.
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.
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)
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.
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.
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)
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.
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 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.
The purpose of this investigator-initiated study is to determine whether the use of an accessory device called AmplifEYE can improve colonoscopy quality in patients who are undergoing average risk colorectal cancer screening. Primary end point is adenoma detection rates.
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.
Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage. During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps. "Withdrawal time" is the period of time the doctor spends examining the colon. Doctors usually spend six minutes examining the colon after they reach the end of the colon. Studies have showed that spending more withdrawal time detects more lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon. There will be no other changes in the procedural aspect of the colonoscopy.
Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk individuals with no family history of CRC. The purpose of this study is to determine the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors associated with the presence of advanced adenomas. This data will provide evidence to determine appropriate colon cancer screening guidelines in 40-49 year old persons with a family history of colon polyps or colorectal cancer.
This randomized phase II clinical trial studies how well MUC1 peptide-poly-ICLC adjuvant vaccine works in treating patients with newly diagnosed advanced colon polyps (adenomatous polyps). Adenomatous polyps are growths in the colon that may develop into colorectal cancer over time. Vaccines made from peptides may help the body build an effective immune response to kill polyp cells. MUC1 peptide-poly-ICLC adjuvant vaccine may also prevent the recurrence of adenomatous polyps and may prevent the development of colorectal cancer.
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).
This simple technique of attaching a transparent cap to the tip of the colonoscope has been evaluated in Japan for improving the detection of polyps and cecal intubation but has not been formally evaluated in the US and other western countries. In one study (19), the polyp detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04). Also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). In a recently published study, a variation of the cap called the transparent retractable extension device was used (21). Overall, the number of adenomas detected were significantly higher with the device compared to without it (205 vs. 150, p=0.04). In an earlier study by Tada et al (22), use of a transparent cap improved the detection rate of lesions per patient (0.86 vs. 0.58) but did not increase the cecal intubation time. Finally, Lee et al (20) used cap assisted colonoscopy in patients with difficult colonoscopy procedure (defined as failure to pass through sigmoid colon after 20 minutes or failure to reach cecum). Using the cap, cecal intubation was achieved in 94% of patients and this proved to be an effective rescue method for failed or difficult colonoscopy. The major appeal of this technique is that it is inexpensive, very practical, and easy to use. Furthermore it is safe and there are no reported complications from this. If found to be effective in increasing the polyp yield it has the potential to being incorporated by busy gastroenterologists in their day to day clinical practice. These features and the preliminary data from Japan merit the evaluation of this promising technique in the US.
The study team has developed a set of biomarkers of risk for colon cancer; this study tests 1) whether or not calcium and/or vitamin D supplementation can favorably affect these biomarkers in persons who are at higher than average risk for colon cancer (ie, have already undergone the removal of colon growths, called adenomatous polyps, which are known to be precursors to developing colon cancer), and 2) whether effects on the biomarkers predict who will get new colon polyps or not.
Based on prior studies, trainee and practicing gastroenterologists miss pre-cancerous polyps (adenomas and serrated polyps) during colonoscopy. The use of computer-aided detection (CADe) systems, a form of artificial intelligence (AI) has been shown to help identify colorectal lesions for practicing gastroenterologists. However, less is known how AI impacts polyp detection for trainees. The investigators are conducting a tandem colonoscopy study wherein a portion of the colon is examined first by the trainee and then the attending physician. For each procedure, randomization will occur which will determine whether or not the trainee will utilize AI for their examination of the colon. At the end of the study, the investigators will determine whether AI helps trainees miss fewer polyps during colonoscopy. The investigators will also conduct interviews with trainees to understand how AI impacts colonoscopy training.
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.
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 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 purpose of this observational study is to record performance of a double balloon endolumenal interventional platform during complex colon polypectomy.
SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare.
With this study, the investigators plan to review the clinical, epidemiology, pathology, and endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of these lesions. The findings will help us define the natural history of colon serrated lesions, develop techniques for endoscopic management of patients with serrated lesions, and identity areas for improvement. The data will be used for continuing quality improvement and presenting our outcomes at academic meetings and publishing our results in peer reviewed journals.
Randomized prospective multi-site validation study.
To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard view colonoscopy. To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with 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.
In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).
In a prospective, randomized, controlled study, two methods (water method vs. air method) of performing colonoscopy will be compared in patients undergoing unsedated colonoscopy for CRC screening. The investigators hypothesize that: 1. Study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy 2. Study method improves bowel preparation and increases polyp pickup rate
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.
The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon. The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.