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

April 29, 2025 updated by: IHU Strasbourg

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Strasbourg, France, 67000
        • Recruiting
        • Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Leonardo SOSA-VALENCIA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of the EUS navigation system's procedure duration compared to standard procedure times
Time Frame: 1 day
Comparison of the examination period duration between the two groups (experimental vs control)
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of the EUS navigation system for patient safety
Time Frame: 1 month
Rate of adverse events, adverse device effects and complications
1 month
Assessment of the system's ease-of-use and technological maturity
Time Frame: 1 day
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
Time Frame: 1 day
Rate of device deficiencies during the procedure
1 day
Evaluation of the time required to perform individual step duration
Time Frame: 1 day
Comparison of the duration of each individual step
1 day
Recording of procedure data for offline systeme performance assessment
Time Frame: 1 day
Collection and prospective review of EUS data, including video and electromagnetic coordinates provided by the sensor
1 day
Assessment of the registration method
Time Frame: 1 day
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IHU Strasbourg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IRCAD

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leonardo SOSA-VALENCIA, MD, IHU Strasbourg, HUS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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