New navigation system for endoscopic ultrasound in pancreatic disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intensive 4-week postoperative multimodal rehab after proximal pancreatic surgery

  This study tests whether a 4-week multimodal rehabilitation program can help adults who have severe complications after proximal pancreatic surgery recover better.

  Recruiting IRCCS San Raffaele · Milan · NCT07768384

• New lipase NHS7108 safety and potential efficacy in adults with exocrine pancreatic insufficiency

  A 2-period study tests whether the new lipase NHS7108 works safely for adults with EPI by comparing it to the standard pancrelipase (Zenpep) at several doses over 14 days each.

  Recruiting at 7 sites Phase 2 Société des Produits Nestlé (SPN) · Scottsdale, Arizona and 38 other locations · NCT07559175

• Dabrafenib and trametinib for rare cancers with BRAF V600 mutations

  This arm tests whether dabrafenib and trametinib can help adults, children, and teens with cancers that have a BRAF V600 mutation.

  Recruiting at 15 sites Phase 2/3 Cancer Research UK · Belfast and 26 other locations · NCT07440290

• Early diagnosis of pancreatic cancer using duodenal fluid biomarkers

  This project will see if pancreatic fluid collected during routine endoscopy can help detect early pancreatic cancer in adults.

  Recruiting at 3 sites Asan Medical Center · Aurora, Colorado and 2 other locations · NCT07030348

• Paracetamol with ibuprofen versus paracetamol with metamizole for pain in children with acute pancreatitis

  We will test whether IV paracetamol combined with ibuprofen or IV paracetamol combined with metamizole reduces pain more effectively in children aged 3–18 with acute pancreatitis.

  Recruiting Phase 4 Medical University of Warsaw · Warsaw · NCT07024199

• Using Ondansetron to Prevent Pancreatitis After ERCP

  This study is testing if the medication ondansetron can help prevent pancreatitis in adults who are having an ERCP procedure.

  Recruiting Phase 3 Tanta University · Tanta · NCT06861010

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.