An interventional study of endoscopic ultrasound with navigation system in Pancreatic Diseases, sponsored by IHU Strasbourg. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by IHU Strasbourg · Not applicable, Interventional, and Other
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.
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).
184 studies on the registry are indexed under Pancreatic Diseases; 63 are open to participants now.
This study's planned enrollment of 64 is below the median of 96 across 104 interventional studies indexed under Pancreatic Diseases.
Browse Pancreatic Diseases studies →IHU Strasbourg is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Perprocedure exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EUS with the experimental navigation system
Device: endoscopic ultrasound with navigation system
EUS in standard condition
Use of the EZ-EUS navigation system during the procedure
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)
Time frame: 1 day
Assessment of the EUS navigation system for patient safety
Rate of adverse events, adverse device effects and complications
Time frame: 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.
Time frame: 1 day
Assessment of the EUS navigation system for reliability
Rate of device deficiencies during the procedure
Time frame: 1 day
Evaluation of the time required to perform individual step duration
Comparison of the duration of each individual step
Time frame: 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
Time frame: 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
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Jan 2026, 12 months after the start.
Of 32 interventional studies with no phase under Pancreatic Diseases, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 44. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
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