Study of the Gixam Device to Detect Colon and Rectal Pre-Cancer or Cancer in Adults Aged 45 to 84 with Negative FIT Results

What this Trial Is About

Researchers are evaluating the Gixam device to see if it can effectively identify adults aged 45 to 84 who have pre-cancer or cancer in the colon and rectum despite having a negative result on a Fecal Immunochemical Test FIT. This study focuses on people considered at average risk for colorectal cancer and aims to assess both the devices accuracy and safety compared to standard screening methods. Participants in this study will undergo three procedures the Gixam test, a FIT at home with stool sample mailing to a lab, and a standard screening colonoscopy which serves as the gold standard for comparison. All participants will receive the same interventions to ensure consistent evaluation of the Gixam system. During the study, participants will complete the Gixam test and FIT, followed by a screening colonoscopy. Researchers will monitor safety from enrollment through 30 days after the study ends and assess efficacy based on findings during this period. The main outcomes include the devices ability to detect colorectal neoplasia and its safety profile. Participation involves multiple visits and procedures over approximately one month.

Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population