Translational trial outcomes for capsule endoscopy test devices

Current clinical standards in the endoscopic diagnosis of gastrointestinal diseases are primarily based on the use of optical systems. Ultrasound has established diagnostic credibility in the form of endoscopic ultrasound (EUS), however it is limited to examination of the upper gastrointestinal tract (oesophagus, stomach and upper (proximal) small bowel). Access to the remainder of the small bowel is currently limited to optical capsule endoscopes and a limited number of other modalities as these capsules are restricted to visual examination of the surface or mucosa of the gut wall. Ultrasound capsule endoscopy has been proposed to integrate microultrasound imaging capabilities into the existing capsule format and extend examination capabilities beyond the mucosa. To establish the ability of high frequency ultrasound to resolve the histological structure of the gastrointestinal tract, ex vivo scans of pig and human tissue were performed. This was done using 25 and 34 MHz single element, physically focused composite transducers mechanically scanned along the tissue. Tethered prototype devices were then developed with 30 MHz physically focused polyvinylidene fluoride (PVDF) single element transducers embedded for use in initial translational trials in the small bowel of porcine subjects. B-scan images from the ex vivo model validation and the in vivo trials are presented.