First-in-human Integrated Endoscopic Ultrasound (EUS) Navigation System Clinical Study

The complexity of the medical expertise required for endoscopic manipulation and image interpretation complicates the implementation of echo-endoscopy (or EUS for "Endoscopic Ultrasound"). The "EZ-EUS" system is designed to help the operator understand the orientation and the position of the probe tip in the patient. This system offers navigation similar to that of the Global Positioning System (GPS), but for EUS procedures. To achieve this, it uses a 3D model based on scanner imaging data recorded before the procedure. In this study, the intended purpose of the "EZ-EUS" system is to help echo-endoscopy operators to easily identify and assess the pancreatic gland, and to facilitate the detection of any lesions. The hypothesis is that, thanks to this tool, procedure times will be shortened, and the pancreas and its lesions will be fully imaged to facilitate their localization and characterization.

NCT Number	NCT06798545
Lead Sponsor	IHU Strasbourg Collaborators: IRCAD
Conditions	Pancreatic Diseases
Enrollment	64 participants
Start Date	2025-01-28
Primary Completion	2026-01 (estimated)
Study Completion	2026-03 (estimated)
Updated on ClinicalTrials.gov	2025-04-30