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Search / Trial NCT06798545

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

Launched by IHU STRASBOURG · Jan 27, 2025

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Endoscopic Ultrasound Eus Navigation Pancreatic Disease Training Education Learning Curve

ClinConnect Summary

This clinical trial is studying a new system called "EZ-EUS," which is designed to assist doctors during a specific procedure known as Endoscopic Ultrasound (EUS) for examining the pancreas. The EZ-EUS system works like a GPS, helping doctors understand exactly where they are in the body and making it easier to find and assess any issues with the pancreas, such as lesions or signs of disease. The goal of the study is to see if this new system can make the procedure quicker and more effective.

To participate in this trial, patients must be at least 18 years old and scheduled for an EUS procedure related to their pancreas. They should have imaging results that show a lesion or other pancreatic concerns, and their scans must be clear and recent. Unfortunately, not everyone can join; for instance, those with certain prior surgeries or health conditions that could complicate the procedure will be excluded. If eligible, participants can expect to undergo the EUS procedure using the new system, which aims to improve the overall experience and outcomes.

Gender

ALL

Eligibility criteria

  • 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, 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.
  • 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 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.
  • 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 \>3. Patient with ASA=3 must be validated by the Principal
  • Investigator (PI).
  • Patient unable to tolerate general anesthesia.
  • Patient with a body mass index (BMI) \< 18,5 and \> 40.
  • Patient with weight variations \>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
  • Perprocedure exclusion criteria
  • • Patient in need of the balloon during the navigation will be excluded of the study (Experimental group)

About Ihu Strasbourg

IHU Strasbourg, or the Institute of Health and Technology of Strasbourg, is a leading research institution dedicated to advancing clinical and translational research in the fields of health and technology. With a focus on innovative therapeutic solutions, IHU Strasbourg collaborates with academic, clinical, and industrial partners to design and implement cutting-edge clinical trials. The institute aims to enhance patient care through rigorous scientific inquiry and the development of novel medical interventions, while adhering to the highest ethical standards in research. Its commitment to excellence positions IHU Strasbourg as a pivotal player in the landscape of clinical research and healthcare innovation.

Locations

Strasbourg, , France

Patients applied

0 patients applied

Trial Officials

Leonardo SOSA-VALENCIA, MD

Principal Investigator

IHU Strasbourg, HUS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported