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A Study to Examine the Effect of Ginger on the Gut Microbiome
Mankato, MN
The purpose of this study is to estimate the impact of a 6‐week daily intake of 2000 mg of ginger extract on the composition of the gut microbiome using a randomized placebo-controlled double-blinded design, i.e. examine the change of microbiome over time within and between the subjects..
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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 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).
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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.