Pancreatic DiseasesEZ-EUS1NCT06798545
First-in-human Integrated Endoscopic Ultrasound (EUS) Navigation System Clinical Study
A study testing endoscopic ultrasound with navigation system in people with Pancreatic Diseases, run by IHU Strasbourg at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Diseases
- What is being tested?
- endoscopic ultrasound with navigation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Leonardo SOSA-VALENCIA, MD, +33390413657, leonardo.sosa-valencia@ihu-strasbourg.eu
Leonardo SOSA-VALENCIA, MD
About this study
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.
Read more
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.
Read the 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).
- Conditions
- Pancreatic Diseases
- Being tested
- endoscopic ultrasound with navigation system
- Keywords
- endoscopic ultrasound, EUS, navigation, pancreatic disease, training, education, learning curve
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ultrasound with navigation systemDevice
Use of the EZ-EUS navigation system during the procedure
| Study group | Role | What they receive |
|---|---|---|
| EUS with EZ-EUS navigation system | Experimental | EUS with the experimental navigation system Receives: Device: endoscopic ultrasound with navigation system |
| Standard EUS | No intervention | EUS in standard condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 day
Secondary outcomes (6)
Assessment of the EUS navigation system for patient safety
Rate of adverse events, adverse device effects and complications
Measured: 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.
Measured: 1 day
Assessment of the EUS navigation system for reliability
Rate of device deficiencies during the procedure
Measured: 1 day
Evaluation of the time required to perform individual step duration
Comparison of the duration of each individual step
Measured: 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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start28 Jan 2025
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Collaborators
- IRCAD
- Responsible party
- Sponsor
- Investigators
- Leonardo SOSA-VALENCIA, MD, Principal investigator, IHU Strasbourg, HUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798545
- Sponsor's protocol ID
- 23-002
- Acronym
- EZ-EUS1
- Status last verified
- Apr 2025
- First submitted
- 21 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human Integrated Endoscopic Ultrasound (EUS) Navigation System Clinical Study
- ClinicalTrials.gov ID
- NCT06798545
- Acronym / sponsor ID
- EZ-EUS1 / 23-002
- Conditions
- Pancreatic Diseases
- Keywords
- endoscopic ultrasound, EUS, navigation, pancreatic disease, training, education, learning curve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Collaborators
- IRCAD
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS with EZ-EUS navigation system | Experimental | Device: endoscopic ultrasound with navigation systemEUS with the experimental navigation system |
| Standard EUS | No intervention | –EUS in standard condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic ultrasound with navigation systemUse of the EZ-EUS navigation system during the procedure | Device | EUS with EZ-EUS navigation system |
Primary outcome
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)
6 secondary outcomes
Assessment of the EUS navigation system for patient safety
Time frame: 1 month
Assessment of the system's ease-of-use and technological maturity
Time frame: 1 day
Assessment of the EUS navigation system for reliability
Time frame: 1 day
Evaluation of the time required to perform individual step duration
Time frame: 1 day
Recording of procedure data for offline systeme performance assessment
Time frame: 1 day
Assessment of the registration method
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leonardo SOSA-VALENCIA, MD principal investigator
IHU Strasbourg, HUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic ultrasound with navigation system in people with Pancreatic Diseases, run by IHU Strasbourg at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armelle TAKEDA, PhD (+33390413608, armelle.takeda@ihu-strasbourg.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the EUS navigation system's procedure duration compared to standard procedure times (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.