New navigation system for endoscopic ultrasound in pancreatic disease
First-in-human Integrated Endoscopic Ultrasound (EUS) Navigation System Clinical Study
This study is testing a new navigation tool for endoscopic ultrasound to see if it helps doctors find and examine pancreatic problems more accurately and quickly for patients with pancreatic disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IHU Strasbourg Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06798545 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the EZ-EUS system, a novel navigation tool designed to enhance the accuracy of endoscopic ultrasound (EUS) procedures for pancreatic diseases. By utilizing a 3D model based on pre-procedure imaging data, the system aims to assist operators in locating and assessing the pancreatic gland and any associated lesions. The study hypothesizes that this technology will reduce procedure times and improve imaging quality, ultimately leading to better patient outcomes. Participants will undergo EUS procedures with the EZ-EUS system as part of their clinical care.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 scheduled for an EUS procedure related to pancreatic evaluation with a clear imaging indication of a lesion or chronic pancreatitis.
Not a fit: Patients with altered or abnormal anatomy of the upper digestive tract or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this system could significantly improve the accuracy and efficiency of EUS procedures for patients with pancreatic conditions.
How similar studies have performed: While the use of navigation systems in endoscopic procedures is emerging, this specific approach with the EZ-EUS system is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Strasbourg
- Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Leonardo SOSA-VALENCIA, MD — IHU Strasbourg, HUS
- Study coordinator: Armelle TAKEDA, PhD
- Email: armelle.takeda@ihu-strasbourg.eu
- Phone: +33390413608
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.