First-in-human Integrated Endoscopic Ultrasound (EUS) Navigation System Clinical Study (EZ-EUS1)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Diseases
• Intervention / Treatment: Device: endoscopic ultrasound with navigation system

Detailed Description

Since its inception in the 1980s, the field of endoscopic ultrasound (EUS) has experienced significant expansion and evolution and is now a pivotal component of pancreatobiliary assessment. Proficiency in EUS necessitates a synthesis of cognitive and technical competencies encompassing endoscopic manipulation, image interpretation, and an extensive comprehension of intraabdominal anatomical structures. Acquisition of these competencies is a progressive and highly operator-dependent process, and thereby necessitates an extended learning curve for practitioners.

The American Society for Gastrointestinal Endoscopy (ASGE) has recommended the performance of a minimum of 190 supervised EUS for practicing autonomous EUS. However, the compliance of these parameters does not guarantee competence achievement, and there is a wide variability between endoscopists leading to disparities in the techniques' quality and irregular outcomes.

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 assist echo-endoscopy operators in accurately locating the pancreatic gland, conducting a comprehensive evaluation of the region of interest, and facilitating the detection and identification of lesions within it. We hypothesize that this tool will streamline procedure times and enable comprehensive imaging of the pancreas and its lesions, thereby reducing the need for expert guidance for trainees and shortening the EUS learning curve. This study is exploratory, prospective, monocentric and will compare two randomized groups (with and without the EZ-EUS navigation system).

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Armelle TAKEDA, PhD; Phone Number: +33390413608; Email: armelle.takeda@ihu-strasbourg.eu

Study Locations

• France
  • Strasbourg, France, 67000
    • Recruiting
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Leonardo SOSA-VALENCIA, MD; Phone Number: +33390413657; Email: leonardo.sosa-valencia@ihu-strasbourg.eu
    • Principal Investigator: Leonardo SOSA-VALENCIA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EUS with EZ-EUS navigation system; EUS with the experimental navigation system	Device: endoscopic ultrasound with navigation system; Use of the EZ-EUS navigation system during the procedure
No Intervention: Standard EUS; EUS in standard condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the EUS navigation system's procedure duration compared to standard procedure times	Comparison of the examination period duration between the two groups (experimental vs control)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the EUS navigation system for patient safety	Rate of adverse events, adverse device effects and complications	1 month
Assessment of the system's ease-of-use and technological maturity	Qualitative assessment of the system's ease-of-use and technological maturity using questionnaires. Appropriate statistical test will be used to compare each procedure. Results will be presented numerically and graphically.	1 day
Assessment of the EUS navigation system for reliability	Rate of device deficiencies during the procedure	1 day
Evaluation of the time required to perform individual step duration	Comparison of the duration of each individual step	1 day
Recording of procedure data for offline systeme performance assessment	Collection and prospective review of EUS data, including video and electromagnetic coordinates provided by the sensor	1 day
Assessment of the registration method	Quantitative (numerical) assessment of registration accuracy using Target Registration Error (TRE), defined as the distance between the predicted 3D location of an anatomical landmark by the navigation system and its true 3D location	1 day

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Collaborators: IRCAD
• Investigators: Principal Investigator: Leonardo SOSA-VALENCIA, MD, IHU Strasbourg, HUS

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: education; training; endoscopic ultrasound; EUS; navigation; learning curve; pancreatic disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: 23-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No