First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study (APEUS-Nav1)

This is an interventional other trial for Pancreatic Disease focused on measuring Endoscopic ultrasound, EUS, Biliopancreatic, Pancreatic cancer, PDAC, EUS navigation, Education, Training, Learning curve, Quality indicators Read More

Inclusion Criteria:

• Man or woman over the age of 18 years old
• Patient having a EUS procedure for pancreas study planned within the frame of his or her clinical care.
• Patient whom pre-operative imaging indicates one lesion with a good definition on the triphasic CT scan done within the 60 days prior to the EUS.
• Patient able to receive and understand information related to the study and give his or her written consent
• Patient affiliated to the French social security system

Exclusion Criteria:

• Patient unable to give informed consent
• Patient with altered anatomy of the upper digestive tract due to previous surgery
• Patient with known abnormal anatomy of the upper digestive tract
• Patient wearing a metal implantable device (pacemaker, etc.)
• Patient presenting, according to the investigator's judgment, a disease which may prevent participation in the procedures provided for by the study
• Patient with an ASA (American Society of Anesthesiologists) score >2
• Patient with multiple pancreatic lesions.
• Patient unable to tolerate general anaesthesia
• Patient with a body mass index (BMI) < 23 and > 40
• Patient with weight variations of >10% between the date on which the CT scan was performed and the date of the procedure.
• Pregnant or lactating patient
• Patient in exclusion period (determined by a previous or a current study)
• Patient under guardianship or trusteeship
• Patient under the protection of justice of deprives of liberty
• Patient in situation of emergency