Clinical trial · Interventional
First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): End of project funding and inclusion difficulties do not justify a request for extension.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS navigation system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- EUS-NS +
- description
- EUS with the navigation system first on, then off
- interventionNames
- Device: EUS navigation system
- type
- EXPERIMENTAL
- label
- EUS-NS -
- description
- EUS with the navigation system first off, then on
- interventionNames
- Device: EUS navigation system
- type
- NO_INTERVENTION
- label
- EUS group
- description
- EUS alone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available