Pilot Study Using a Retrograde Tethered Capsule Endomicroscope to Image the Lower Gastrointestinal Tract in Adults

What this Trial Is About

Researchers are evaluating a new, low-cost imaging tool that captures pictures of the lower gastrointestinal GI tract without the need for sedation. This device is a capsule about the size of a fish oil or multi-vitamin supplement, attached to a string and connected to a motor. The study includes healthy adults and adults diagnosed with Lynch Syndrome, Crohns Disease, or Inflammatory Bowel Disease, aiming to assess the devices ability to capture quality images of the lower GI tract. The tool, called the Retrograde Tethered Capsule Endomicroscope R-TCE device, is inserted into the participants lower GI tract and moves upward through a slow spiral motion controlled by the motor. The capsule is connected to an imaging system that saves and displays images in real time. The study will enroll 30 participants who will all receive this same intervention. Participants are grouped into healthy adults and adults with specific gastrointestinal conditions. During the study, the devices image quality and tolerability will be assessed, including participants experiences without sedation. Imaging data will be collected during the procedure and analyzed within one year. Participants will follow bowel preparation instructions before the procedure. The study will monitor for any adverse effects and evaluate how well the capsule is tolerated on the day of the procedure. Total participation time varies with individual schedules.

A Study for Imaging the Lower Gastrointestinal Tract Using a Retro-TCE Capsule