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Endoscopic Resection of Large Colorectal Polyps
Jacksonville, FL
The purpose of this study is to understand how to improve polyp resection of large polyps, and how to make it as effective and as safe as possible.
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Cold Snare EMR Trial
Jacksonville, FL
The primary aim of the study is to compare safety and effectiveness of two methods of endoscopic resection of large colorectal polyps: cold snare EMR (without electrocautery) vs. hot snare EMR (with electrocautery).
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Gastroenterology Artificial INtelligence System for Detecting Colorectal Polyps (The GAIN Study) (GAIN)
Rochester, MN
The purpose of this research is to evaluate the accuracy of a medical device that has been developed to automatically find polyps (small growths) during colonoscopies. The device uses a computer to detect and highlight potential polyps from the usual video images made during a colonoscopy, and such detections will be visible to the doctor during the regular colonoscopy procedure. This medical device is called Endoscopy Video Assistance for Colonoscopy (EVA-C). EVA-C, an investigational device, has been developed to assist the doctor in identifying possible polyps, but is not meant to replace their decision making.
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Evaluation of C-Scan Capsule in Identifying Subjects With Elevated Risk of Colon Polyps
Rochester, MN; Scottsdale/Phoenix, AZ
The main objective of the study is to determine the ability of the C-Scan system to identify subjects who are at elevated risk for colon polyps. This will be evaluated by comparing the C-Scan data to colonoscopy data. The C-Scan procedure is therefore performed before the colonoscopy procedure, in order to compare these tests and evaluate the C-Scan system's effectiveness. During the C-scan procedure, Subjects will be asked to come for an appointment in a clinic. during this appointment, The C-Scan Track will be attached to the subject's back. Subjects then will be asked to swallow the C-Scan capsule ...
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A Study to Evaluate the Accuracy of the CapsoCam® Colon (CV-3) in Detecting Colonic Polyps Compared to Colonoscopy
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of CapsoCam® Colon (CV-3) endoscope system for the detection of colonic polyps. It is anticipated that the data from this clinical trial will be used to support marketing authorizations to commercialize the CapsoCam® Colon (CV-3).
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A Study to Evaluate Colorectal Polyps with Dietary Inflammation During Colonoscopy
Jacksonville, FL
Colorectal cancer is the third most commonly diagnosed cancer in both men and women in the United States (1). Colorectal cancer arises from colonic polyps. The major types of polyps associated with colorectal cancer development are adenomatous (tubular which is most common and other types are villous and tubulovillous) and serrated (hyperplastic, sessile or traditional) polyps with varying degrees of dysplasia (2). Hyperplastic polyps are common but they have a low malignancy potential (3). There is evidence that colonic inflammation plays a major role in colon polyp and colorectal cancer development. For example, inflammatory bowel disease is a major ...
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A Quality of Life Assessment of Patients with Biliary Obstruction Undergoing Endoscopic or Percutaneous Drainage
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The aim of this study is to compare the quality of life of patients with biliary obstruction who have undergone an endoscopic or percutaneous drainage. The quality of life of patients witll be assessed using the validated "European Quality of Life-5 Dimensions Questionnaire" and the "Intervention-Dependent Questionnaire" which was developed according to current literature as well as the expert opinion of gastroeneterologists.
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A Study of the Safety of Using SIC 8000 in Patients Undergoing Endoscopic Mucosal Removal of Colon Lesions Equal to or Larger Than 2 cm
Jacksonville, FL
The purpose of this study is to assess the effectiveness of SIC 8000 injected into the submucosa under polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions to provide a lift to them prior to grasping and cutting with a snare during endoscopic removal procedures.
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Soft Coagulation for the Prevention of Adenoma Recurrence
Jacksonville, FL
The purpose is to investigate whether a simple additional treatment applied during colonoscopy (called 'soft' coagulation) can reduce the risk of recurrence of polyp at the area where the polyp was removed. After a large polyp is removed it is known that there is a 20% chance that a small recurrence of polyp occurs at the site of removal can occur within 5 months of the polyp being removed. This in theory will burn off tiny polyp tissue, which is usually not visible to the naked eye. This additional treatment may possibly reduce the risk of polyp recurrence.
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A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a proof-of-concept study to evaluate the preliminary clinical activity of guselkumab in subjects with Familial Adenomatous Polyposis. The study is designed to determine if guselkumab has clinical activity in the colorectum and duodenum, by reducing the number of polyps over a period of 24 weeks.
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A Study to Evaluate the Safety and Effectiveness of the Augmented Endoscopy System for Mucosal Lesion Detection During Colonoscopy for Colon Rectal Cancer.
Scottsdale/Phoenix, AZ; Jacksonville, FL; La Crosse, WI; Eau Claire, WI
The purpose of this study is to confirm the performance of the CB-17-08 software as a medical device (SaMD) to help endoscopist during the colonoscopy procedure to find potential mucosal lesions, including polyps, adenomas and carcinomas, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard endoscopy video alone. The study will evaluate whether high-definition white-light (HDWL) colonoscopy using CB-17-08 SaMD will have a lower miss rate of clinically significant polyps, as compared to standard HDWL colonoscopy alone (the current standard of care for colonoscopy).