19 Clinical Trials for Various Conditions
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.
You are invited to participate in a research study to develop new ways to look for abnormal areas/tissues of the colon. The current endoscopes used to look at the colon are very good, but if the area doesn't look different to the naked eye, then the endoscope can't improve on that. We are looking at using special fluorescent stains in addition to special endoscopes designed to see abnormal areas that are not obvious to the naked eye. Currently specialized microscopes and fluorescent stains are used in clinical laboratories but it takes several days of processing to get results. It may be very helpful to look for areas to sample for abnormal tissue during the endoscopy procedure. You are being asked to let us spray a "fluorescent peptides" into your right colon. Peptides are small chains of amino acids (the building blocks that make up proteins) linked together. Our peptide is a chain of 7 amino acids attached to a fluorescent dye called FITC (like the one used by your eye doctor). We have prepared this special "fluorescent peptide" to target and bind to any abnormal areas if present, and "glow" when a special light is used. In this study, we will apply the special fluorescent peptide by a spray catheter to your right colon to asses for safety. The colonoscope used in this study is the usual colonoscope used and is not able to see the fluorescence. This is a phase 1 study. This means that this is the first time we have used this kind of "fluorescent peptide" in people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing us to test it in this study. The goal of this study is to see if there are any side effects from using the peptide. We have used a similar peptide that we've developed for the esophagus in over 40 patients without any side effects. This is the first test of this agent, so it won't be used to change how colonoscopy is done.
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 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 PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.
Standard white light endoscopy involves the passage of a thin, flexible camera into the colon from the anus. Although standard white light endoscopy can detect most polyps and precancerous areas in the gastrointestinal tract and colon, many studies have shown that even the most experienced doctors, under optimal conditions, can miss up to 15-25% of precancerous areas. Thus, there remains a clear need to develop new methods of improving standard white light endoscopy. We are investigating whether indocyanine green (ICG) can serve to highlight areas which are precancerous when the colon is visualized with a special cameral which shines fluorescent light. Information from other studies suggests that this ICG agent may help to visualize blood vessels flowing to precancerous areas in the colon. We are looking at the ability of ICG, in combination with an endoscope which shines fluorescent light, to visualize precancerous areas in the colon.
The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied. Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is also designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.
This is a study to determine if using Narrow-Band Imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using Narrow-Band Imaging will make it easier to see them, as they can be quite difficult to see with standard white light.
Protocol Title: Evaluation of safety, usability and subject compliance while using Check- Cap's C-Scan System for providing structural information on colonic polypoid lesions and masses Study Design: Prospective, Multi-center, Single-arm, safety study Purpose: To demonstrate the safety of the Check-Cap C-Scan System Study Centers: Up to two (2) centers located in the United States Number of Participants: 45 healthy subjects Investigational Device: Check-Cap's C-Scan System comprises C-Scan Capsule, C-Scan Track and C-Scan View. Primary Objective: To evaluate the safety of the Check-Cap C-Scan System Secondary Objectives: a. To evaluate subject's compliance b. To evaluate subject's satisfaction c. To collect data to improve the product's algorithm
The goal of this clinical trial is to evaluate oxygenation in the colon in people with acquired vascular abnormalities in the proximal colon.
The aim of this study is to assess the performance of the CB-17-08 to help endoscopists find potential mucosal polyps during the colonoscopy procedure, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard colonoscopy alone: the study will investigate whether the use of the device provides an increase in the number of adenomas per colonoscopy as compared to standard colonoscopy. The study will also evaluate the safety of the CB-17-08, assessing if the use of the system increases the total number of excisions without a commensurate number of adenomas as compared to standard colonoscopy.
To assess the safety and performance of the Medrobotics Flex Robotic System and Flex Rectoscope for accessing and visualizing the Anus, Rectum, and Distal Colon when used for Transanal procedures
To compare 2 different image creation/processing techniques during a standard CT scan in order to "see" problems in the liver and learn which method provides better image quality. The techniques use new artificial intelligence software to decrease image noise, which helps the radiologist to evaluate.
With this study, the investigators plan to review the performance of colonoscopic resection of large (\> 1 cm) and flat lesions in the colon. The findings will help us define the role of colonoscopic resection of colon polyps and flat 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.
This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy. This study will also use to evaluate the administrative feasibility and data management of study design.
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.
The recently developed endoscopic Confocal probe microscopy system allows imaging of surface epithelium during ongoing endoscopy (upper and lower) with the potential of immediate diagnosis of various GI pre-malignant and malignant lesions. The purpose of this study is to determine if using this new Confocal probe system can find pre-cancerous abnormalities in the stomach and colon. Hypothesis: The confocal endomicroscopy images of colorectal lesions during the standard colonoscopies could help the classification in vivo of colorectal neoplastic and non-neoplastic lesions. This could direct further endoscopic interventions such as targeted biopsies of early colorectal cancer lesions and the endoscopic resection of such lesions during screening colonoscopies. Primary Aim 1. To determine the key confocal image features of neoplastic and pre-neoplastic colorectal lesions including flat and raised adenomatous polyps, intraepithelial neoplasia and cancer as well as benign lesions such as hyperplastic polyps and normal colonic epithelium and to estimate which morphologic features best distinguish neoplastic and non-neoplastic tissues. Secondary Aims: 2. To determine the initial sensitivity and specificity of confocal microendoscopy imaging for classification of adenomatous from hyperplastic polyps of the colon. 3. In this exploratory phase of the study to develop a library of confocal microendoscopic imaging characteristics of other GI pathologies such as: 1. Barrett's esophagus in comparison to Barrett's esophagus with dysplasia, and normal squamous esophagus. 2. Other encountered inflammatory and neoplastic conditions within the GI tract in which biopsy or removal of tissue would routinely be indicated. The second phase of the study will focus on establishing the sensitivities, specificities, accuracy of confocal images of colorectal lesions and other GI pathologies as well as inter-observer agreement and learning curve in interpretation of confocal images.
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.
We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high definition white light colonoscopy will detect an increased number of nonpolypoid (flat and depressed) colorectal neoplasm.