First-in-human Integrated Endoscopic Ultrasound (EUS) Navigation System Clinical Study
ConditionPancreatic Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIHU Strasbourg
About this trial
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.
Eligibility criteria
Qualifiers
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, a suspicion of lesion, chronic pancreatitis or fatty pancreas.
Patient with a good definition on the CT scan done within the year to the EUS.
Disqualifiers
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 pacemaker.
Patients with comorbidities that may increase the risk of perforation.
Trial design
Treatments tested in this trial
- endoscopic ultrasound with navigation system
Treatment groups
64 Participants
are divided into 2 treatment groupsSponsors and collaborators
IHU Strasbourg
Lead sponsor
IRCAD
Collaborator
Source ClinicalTrials.gov