A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdomino… (NCT07199348) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding
45 participantsStarted 2025-10
Plain-language summary
This research conducted by EMBOBIO SAS is intended for patients with bleeding or at risk of bleeding in the abdominal-pelvic region requiring embolization.
The EmboBio device (embolization implant) is a Class IIb medical device that is not CE marked (meaning that it is not yet commercially available on the European market).
The objective of the study is to demonstrate the safety and performance of the EmboBio medical embolization device in humans in order to obtain CE marking, the European authorization required for the commercialization of medical devices.
Safety will be assessed by collecting data on events that may be related to the device, and the device will be considered effective if the target arteries are completely occluded (blocked) at the end of the operation.
The plan is to include 45 patients (men and women aged 18 or over who have given their consent to participate in the study) requiring embolization in the abdominal-pelvic region in French hospitals over a period of 12 months. The patient's full participation is requested for a period of approximately 6 months.
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:
* Age ≥18 years
* Patient presenting with an arterial abdominopelvic bleeding or risk of bleeding requiring embolization with a permanent embolic agent, i.e. abdominal solid organs hemorrhage including angiomyolipoma, visceral aneurysms and pseudoaneurysms actively bleeding or at risk of bleeding (upper or lower gastrointestinal arteries), pelvic hemorrhage, postpartum hemorrhage in case of active leakage visualized by contrast media extravasation, soft tissue hemorrhage
* Patient having provided a written informed consent
Exclusion Criteria:
* Known hypersensitivity to Agar-Agar
* Known hypersensitivity to iodinated contrast media
* Patient unable or unwilling to provide a written informed consent
* Patient unable to provide informed consent due to his clinical condition
* Patient participating in another interventional study
* Patient implanted with Embobio device at a previous operating time
* Vulnerable, pregnant, and breastfeeding population
* Patient unwilling or unable to follow the study schedule
* Patients unable to receive prior information on the clinical investigation due to the urgency of the situation
* Target arteries diameter \> 2 mm
* Vascular anatomy preventing proper placement of the catheter.
* Arteriovenous shunts with a high flow rate or a diameter greater than 2 mm
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
Rate of Serious Adverse Device Effects (SADE)
Timeframe: 24 hours
2
Rate of technical success
Timeframe: At the end of the procedure
3
Description of procedural data : dosimetry
Timeframe: At the end of the procedure
4
Description of procedural data : quantity of Embobio
Timeframe: At the end of the procedure
5
Description of procedural data : time to bleeding control
Timeframe: At the end of the procedure
6
Description of procedural data : procedure duration