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

NCT06798545 | Recruiting

• 1 other identifier: 23-002
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Diseases

Keywords

endoscopic ultrasound; EUS; navigation; pancreatic disease; training; education; learning curve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assessment of the EUS navigation system for patient safety

  1 month

• Assessment of the system's ease-of-use and technological maturity

  1 day

• Assessment of the EUS navigation system for reliability

  1 day

• Evaluation of the time required to perform individual step duration

  1 day

• Recording of procedure data for offline systeme performance assessment

  1 day

Study Arms (2)

EUS with EZ-EUS navigation system

EXPERIMENTAL

EUS with the experimental navigation system

Device: endoscopic ultrasound with navigation system

Standard EUS

NO INTERVENTION

EUS in standard condition

Interventions

endoscopic ultrasound with navigation system DEVICE

Use of the EZ-EUS navigation system during the procedure

EUS with EZ-EUS navigation system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 under guardianship or trusteeship.
• Patient under the protection of justice of deprives of liberty.
• Patient in situation of emergency
• Patient in need of the balloon during the navigation will be excluded of the study (Experimental group)

Sponsors & Collaborators

• IHU Strasbourg: lead
• IRCAD: collaborator

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Pancreatic Diseases

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Leonardo SOSA-VALENCIA, MD

  IHU Strasbourg, HUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Armelle TAKEDA, PhD

CONTACT

+33390413608; armelle.takeda@ihu-strasbourg.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 29, 2025
• Study Start: January 28, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)