First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study (NCT05515705) | Clinical Trial Compass
TerminatedNot Applicable
First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study
Stopped: End of project funding and inclusion difficulties do not justify a request for extension.
France21 participantsStarted 2023-01-10
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the EUS navigation system's procedure duration compared to standard procedure times