Randomized Study Comparing EndoSound Vision System and Standard Echoendoscope for Endoscopic Ultrasound in Gastrointestinal Lesion Evaluation

What this Trial Is About

Researchers are comparing the standard echoendoscope with a newly developed device called the EndoSound Visual System to evaluate lesions in the gastrointestinal tract. This trial focuses on improving endoscopic ultrasound EUS examinations, which are commonly used to assess and biopsy lesions in the pancreas, bile duct, lymph nodes, and gastrointestinal tract due to their high sensitivity and accuracy. Participants will undergo EUS examinations using either the standard echoendoscope or the EndoSound Visual System, which attaches externally to a standard endoscope to convert it into an echoendoscope. Each participant will be randomly assigned to one of these two groups, and the EUS procedure will be performed according to standard care practices. During the study, researchers will assess the success rate of completing the EUS examination, ease of device maneuverability, imaging quality, tissue sampling performance, diagnostic adequacy and accuracy of specimens, procedure duration, procedure-related side effects, and costs. These evaluations will take place within one to seven days after the procedure. The total study participation timeline varies by participant based on scheduled assessments and follow-ups.

EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope