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Clinical Trials in France / NCT07199348
Active, not recruiting Not applicable

A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding

NCT07199348 · tracked via the Priya Life Science France tracker
Sponsor
Embobio Medical
Phase
Not applicable
Started
2025-10-08
Last updated
2026-07-02

Condition(s) studied

Abdomino-pelvic SurgeryBleedingEmbolization

Investigational drug(s) / intervention(s)

Embobio

Embobio: Embolization with the device Embobio

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of Serious Adverse Device Effects (SADE) — 24 hours
    The primary endpoint of the pilot stage is the rate of SADE (serious adverse events, probably or certainly related to investigational device deficiencies) within 24 hours.
  • Rate of technical success — At the end of the procedure
    The primary performance endpoint is the technical success defined by the successful achievement of embolization of the target artery/arteries, and the absence of extravasation of contrast of target artery/arteries after arterial embolization at the end of the procedure.
  • Description of procedural data : dosimetry — At the end of the procedure
    Dosimetry data during the procedure
  • Description of procedural data : quantity of Embobio — At the end of the procedure
    Quantity of Embobio used for embolization
  • Description of procedural data : time to bleeding control — At the end of the procedure
    Time needed to control the bleeding
  • Description of procedural data : procedure duration — At the end of the procedure
    Total duration of the procedure

Trial sites (1)

FacilityCityRegionStatus
Hegp-Aphp Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07199348 on ClinicalTrials.gov ↗ ← All trials in France