Pancreatic DiseaseAPEUS-Nav1NCT05515705
First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study
A study testing EUS navigation system in people with Pancreatic Disease, run by IHU Strasbourg at 1 site in France.
Trial summary
The implementation of Echo-endoscopy (or EUS for: Endoscopic UltraSound) is limited by the difficulty of obtaining quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Disease
- What is being tested?
- EUS navigation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 with a good definition on the triphasic CT scan done within the 60 days prior 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 unable to give informed consent
- 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 metal implantable device (pacemaker, etc.)
- 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 (American Society of Anesthesiologists) score >2
Show all 15Show fewer
- Patient with multiple pancreatic lesions.
- Patient unable to tolerate general anaesthesia
- Patient with a body mass index (BMI) < 23 and > 40
- Patient with weight variations of >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
Trial locations and contacts
1 site in 1 country.
About this study
The implementation of Echo-endoscopy (or EUS for: Endoscopic UltraSound) is limited by the difficulty of obtaining quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Indeed, both cognitive and technical skills are required for endoscopic manipulation and image interpretation, as well as a thorough knowledge of intra-abdominal anatomy. The "EUS-GPS" system aims to assist the operator in understanding the orientation and location of the probe tip within the patient. For that, a Global Positioning System (GPS) for EUS procedures is intraoperatively provided, using a 3D-based model based on recorded preoperative data.
In this clinical investigation, the EUS GPS system is intended to help EUS operators to correctly navigate towards the pancreatic gland, perform a comprehensive assessment of the area of interest, and aid in the detection and identification of lesions.
Read the detailed description
Since its emergence in the 1980s, endoscopic ultrasound (EUS) is considered as one of the most accurate tools for the evaluation of the pancreatic gland and other gastrointestinal (GI) disorders. Despite its utility, the practice of EUS is still far from being part of every endoscopy suite due to its high set-up cost and the relative scarcity of credentialed experts. EUS implementation worldwide has been limited by the difficulty of achieving quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Both cognitive and technical competencies are required for endoscopic manipulation and image interpretation, as well as extensive knowledge of intraabdominal anatomy.
The aim of the APEUS (Augmented Pancreatic Endoscopic UltraSound) project is to overcome these two main difficulties by providing a Global Positioning System (GPS)-like intraoperative navigation for EUS procedures, using a 3D-based model on registered preoperative data. The hypothesis is that, thanks to this tool, the procedures time would be shortened, and the pancreas and its lesions would be completely imaged. This would reduce the demand for experts guiding trainees and shorten the EUS learning curve.
This first-in-human clinical study will enable the assessment of safety and qualitative performance of the EUS-GPS solution. The primary objective is to evaluate the EUS navigation system's procedure duration compared to standard procedure times (patient group with the EUS-GPS system vs control group without).
- Conditions
- Pancreatic Disease
- Being tested
- EUS navigation system
- Keywords
- Endoscopic ultrasound, EUS, Biliopancreatic, Pancreatic cancer, PDAC, EUS navigation, Education, Training, Learning curve, Quality indicators
- Medical subject headings
- Pancreatic Diseases, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS navigation systemDevice
Incorporation of the EUS navigation system to the EUS scope
| Study group | Role | What they receive |
|---|---|---|
| EUS-NS + | Experimental | EUS with the navigation system first on, then off Receives: Device: EUS navigation system |
| EUS-NS - | Experimental | EUS with the navigation system first off, then on Receives: Device: EUS navigation system |
| EUS group | No intervention | EUS alone |
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
Collect of peroperative duration for registration, insertion, navigation to cardia, navigation from the cardia to the pancreas, pancreas examination, therapeutic step and overall duration of the procedure (quantitative). Results will be compared between cases with (Groups EUS-NS) and without (Group EUS alone) use of the navigation system
Measured: 1 day
Secondary outcomes (8)
Assessment of the EUS navigation system in terms of reliability and safety
Rate of intraoperative undesirable events and of any event related to the tested system (probe breaking, software crashing, etc.)
Measured: 1 day
Comparison of the EUS navigation system's procedure duration depending on the order the EUS-GPS is used
Collect of peroperative duration for registration, insertion, navigation to cardia, navigation from the cardia to the pancreas, pancreas examination, therapeutic step and overall duration of the procedure (quantitative). Results will be compared between cases with use of the navigation system first (Subgroup EUS-NS +) or in a second time (Subgroup EUS-NS -)
Measured: 1 day
Assessment of the system's ease-of-use (integration in the standard-of-care workflow) compared to the standard procedure by the mean of a questionnaire
Questionnaire to assess the ease-of-use (integration in the standard-of-care workflow) of the EUS navigation system, filled by the EUS endoscopist (qualitative).
Measured: 1 day
Assessment of the system's stressfulness compared to the standard procedure by the mean of a questionnaire
Questionnaire to assess the stressfulness of the EUS navigation system, filled by the EUS endoscopist (qualitative).
Measured: 1 day
Collect adverse events, adverse device effects and device deficiencies
Collect adverse events, adverse device effects and device deficiencies during the procedure and up to 1 month after the EUS
Measured: 1 month
Assessment of registration method by the mean of video recording analysis
A complete video recording of the procedure (endoscopic camera, ultrasound probe, pre-operative data real-time display and external camera) will be performed to assess the precision of the registration, using as anatomical points landmarks detectable in both CT and US images
Measured: 1 day
Collection of EUS data
Videos of the EUS procedure for further use in Artificial Intelligence-driven EUS research projects will be collected if the patient specifically consents to it. Recorded material will include the electromagnetic (EM) coordinates provided by the sensor. EUS video data associated with EM coordinates will be used to build databases for AI-driven EUS research projects
Measured: 1 day
Assessment of technological maturity and ergonomics
Questionnaire to evaluate the ergonomics and technological readiness, filled by the EUS endoscopist (qualitative).
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 posted25 Aug 2022
- Study start10 Jan 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: End of project funding and inclusion difficulties do not justify a request for extension.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic DiseaseStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonardo SOSA VALENCIA, MD, Principal investigator, IHU Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515705
- Sponsor's protocol ID
- 22-003
- Acronym
- APEUS-Nav1
- Status last verified
- Feb 2024
- First submitted
- 23 Aug 2022
- Last updated
- 1 May 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study
- ClinicalTrials.gov ID
- NCT05515705
- Acronym / sponsor ID
- APEUS-Nav1 / 22-003
- Conditions
- Pancreatic Disease
- Keywords
- Endoscopic ultrasound, EUS, Biliopancreatic, Pancreatic cancer, PDAC, EUS navigation, Education, Training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of project funding and inclusion difficulties do not justify a request for extension.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 25 Aug 2022 (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 implementation of Echo-endoscopy (or EUS for: Endoscopic UltraSound) is limited by the difficulty of obtaining quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Indeed, both cognitive and technical skills are required for endoscopic manipulation and image interpretation, as well as a thorough knowledge of intra-abdominal anatomy. The "EUS-GPS" system aims to assist the operator in understanding the orientation and location of the probe tip within the patient. For that, a Global Positioning System (GPS) for EUS procedures is intraoperatively provided, using a 3D-based model based on recorded preoperative data.
In this clinical investigation, the EUS GPS system is intended to help EUS operators to correctly navigate towards the pancreatic gland, perform a comprehensive assessment of the area of interest, and aid in the detection and identification of lesions.
Detailed description
Since its emergence in the 1980s, endoscopic ultrasound (EUS) is considered as one of the most accurate tools for the evaluation of the pancreatic gland and other gastrointestinal (GI) disorders. Despite its utility, the practice of EUS is still far from being part of every endoscopy suite due to its high set-up cost and the relative scarcity of credentialed experts. EUS implementation worldwide has been limited by the difficulty of achieving quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Both cognitive and technical competencies are required for endoscopic manipulation and image interpretation, as well as extensive knowledge of intraabdominal anatomy.
The aim of the APEUS (Augmented Pancreatic Endoscopic UltraSound) project is to overcome these two main difficulties by providing a Global Positioning System (GPS)-like intraoperative navigation for EUS procedures, using a 3D-based model on registered preoperative data. The hypothesis is that, thanks to this tool, the procedures time would be shortened, and the pancreas and its lesions would be completely imaged. This would reduce the demand for experts guiding trainees and shorten the EUS learning curve.
This first-in-human clinical study will enable the assessment of safety and qualitative performance of the EUS-GPS solution. The primary objective is to evaluate the EUS navigation system's procedure duration compared to standard procedure times (patient group with the EUS-GPS system vs control group without).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EUS-NS + | Experimental | Device: EUS navigation systemEUS with the navigation system first on, then off |
| EUS-NS - | Experimental | Device: EUS navigation systemEUS with the navigation system first off, then on |
| EUS group | No intervention | –EUS alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 with a good definition on the triphasic CT scan done within the 60 days prior 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
Key exclusion criteria (15 listed)
- Patient unable to give informed consent
- 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 metal implantable device (pacemaker, etc.)
- 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 |
|---|---|---|
| EUS navigation systemIncorporation of the EUS navigation system to the EUS scope | Device | EUS-NS +, EUS-NS - |
Primary outcome
Evaluation of the EUS navigation system's procedure duration compared to standard procedure times
Time frame: 1 day
Collect of peroperative duration for registration, insertion, navigation to cardia, navigation from the cardia to the pancreas, pancreas examination, therapeutic step and overall duration of the procedure (quantitative). Results will be compared between cases with (Groups EUS-NS) and without (Group EUS alone) use of the navigation system
8 secondary outcomes
Assessment of the EUS navigation system in terms of reliability and safety
Time frame: 1 day
Comparison of the EUS navigation system's procedure duration depending on the order the EUS-GPS is used
Time frame: 1 day
Assessment of the system's ease-of-use (integration in the standard-of-care workflow) compared to the standard procedure by the mean of a questionnaire
Time frame: 1 day
Assessment of the system's stressfulness compared to the standard procedure by the mean of a questionnaire
Time frame: 1 day
Collect adverse events, adverse device effects and device deficiencies
Time frame: 1 month
Assessment of registration method by the mean of video recording analysis
Time frame: 1 day
Collection of EUS data
Time frame: 1 day
Assessment of technological maturity and ergonomics
Time frame: 1 day
Results and safety
The study was stopped early (reason given: End of project funding and inclusion difficulties do not justify a request for extension.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 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. This study is not recruiting at the moment.
Leonardo SOSA VALENCIA, MD principal investigator
IHU Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS navigation system in people with Pancreatic Disease, 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 1 May 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?
The study was stopped early (reason given: End of project funding and inclusion difficulties do not justify a request for extension.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 1 May 2025.