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

NCT06798545 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-04-30

No results posted yet for this study

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

Interventions

DEVICE

endoscopic ultrasound with navigation system

Use of the EZ-EUS navigation system during the procedure

Sponsors & Collaborators

  • IRCAD

    collaborator UNKNOWN

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Leonardo SOSA-VALENCIA, MD · IHU Strasbourg, HUS

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-28
Primary Completion
2026-01-31
Completion
2026-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798545 on ClinicalTrials.gov