Status:
NOT_YET_RECRUITING
A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding
Lead Sponsor:
Embobio Medical
Conditions:
Abdomino-pelvic Surgery
Bleeding
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) i...
Detailed Description
Abdominopelvic bleeding may occur in different and various circumstances, in a spontaneous way, after a trauma, in a neoplasic context, after a visceral aneurysm's rupture, during or after a surgical ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07199348
Start Date
October 1 2025
End Date
April 1 2027
Last Update
September 30 2025
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