Actively Recruiting
First-in-human Integrated Endoscopic Ultrasound (EUS) Navigation System Clinical Study
Led by IHU Strasbourg · Updated on 2025-04-30
64
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
I
IHU Strasbourg
Lead Sponsor
I
IRCAD
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a new integrated navigation system called "EZ-EUS" designed to assist operators during endoscopic ultrasound (EUS) procedures focused on the pancreas. EUS is a complex technique requiring advanced skills in manipulating the endoscope and interpreting images. The study investigates whether the EZ-EUS system can help operators by providing a GPS-like 3D navigation based on pre-procedure imaging to better locate the pancreas and detect lesions, potentially making the procedure faster and easier to perform. Participants will be randomly assigned to one of two groups: one group will undergo EUS with the experimental EZ-EUS navigation system, and the other group will receive standard EUS without the navigation system. The study is prospective, exploratory, and monocentric, comparing procedure times and the effectiveness of lesion detection between the two approaches. The EZ-EUS system uses a 3D model from scanner data recorded before the procedure to guide the operator. During the study, participants will undergo their planned EUS procedure with or without the navigation system. Researchers will evaluate the duration of the procedure, ease of use, safety, reliability, and technical performance of the system. Data will be collected during and after the procedure, with safety assessments extending to one month post-procedure. The total involvement includes the clinical procedure and follow-up as per study timelines to assess the impact of the navigation system on EUS procedures.
CONDITIONS
Brief Title
First-in-human Integrated Endoscopic Ultrasound (EUS) Navigation System Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Scheduled for an EUS procedure to study the pancreas as part of clinical care
- Pre-operative imaging shows one lesion, suspected lesion, chronic pancreatitis, or fatty pancreas
- Good quality CT scan of the pancreas done within one year before the EUS
- Able to understand study information and provide written consent
- Affiliated with the French social security system
You will not qualify if you...
- Altered or abnormal anatomy of the upper digestive tract due to previous surgery or known conditions
- Presence of a pacemaker
- Health conditions that increase risk of perforation
- Diseases judged by the investigator to prevent participation
- ASA score greater than 3 (ASA=3 must be approved by the Principal Investigator)
- Unable to tolerate general anesthesia
- Body mass index less than 18.5 or greater than 40
- Weight change greater than 10% between CT scan and procedure date
- Pregnancy or lactation
- Participation in another trial exclusion period
- Under guardianship, trusteeship, or deprived of liberty
- Emergency medical situations
- Use of balloon during navigation procedure (for experimental group)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo an endoscopic ultrasound (EUS) procedure with or without the use of the EZ-EUS navigation system to assist in locating and evaluating the pancreas and lesions.
1 procedure visit (in-person)
Duration - 1 month
Participants are observed for safety and any adverse effects following the EUS procedure.
Follow-up visits as needed during 1 month
Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
Research Team
A
Armelle TAKEDA, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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