Stopped: Study has been withdrawn per decision of Sponsor.
Belgium, France, India0Started 2025-08-31
Plain-language summary
The goal of this clinical trial is to assess basic feasibility, safety, and performance of an EUS access device in patients with malignant biliary obstruction who are indicated to receive EUS-guided hepaticogastrostomy for biliary drainage. The main questions it aims to answer are:
* Can the device be used to gain and maintain access to target anatomy?
* Does the device have a clinically acceptable safety profile?
* How does the device perform overall?
All patients will undergo a hepaticogastrostomy procedure and be followed for 7 days post-procedure.
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:
* Patient with malignant biliary obstruction and who is indicated to receive EUS-guided hepaticogastrostomy for biliary drainage, as documented by dilated left hepatic duct and hyperbilirubinemia
* Patient who failed ERCP (e.g., inability to access the obstructed biliary system via a transpapillary route) or for whom ERCP is not an option (e.g., due to altered anatomy, gastric outlet obstruction)
* 18 years of age or older
* Patient willing and able to provide written informed consent and comply with specified study visits
Exclusion Criteria:
* Patient whose general medical condition and degree of respiratory failure would not allow them to tolerate endoscopy and/or the manipulation required to perform the study procedure
* Abnormal coagulopathy:
* INR \>1.5 and not correctable
* presence of bleeding disorder
* platelets \<50,000 mm3
* Patient with contraindication to use of electrical devices
* Female of childbearing potential with a positive pregnancy test prior to the procedure or who intends to become pregnant during the study
* Patient from a vulnerable population
* Current participation in another investigational drug or device study that could interfere with the endpoints of this study
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
Technical Success
Timeframe: Day 0 Study Procedure
2
Safety
Timeframe: Day 0 Study Procedure through Day 7 Post-Study Procedure