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

NCT07199348 | Not Yet Recruiting DMC

• 1 other identifier: 2025-A00222-47
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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) 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.

Conditions

Abdomino-pelvic Surgery; Bleeding; Embolization

Outcome Measures

Primary Outcomes (6)

• Rate of Serious Adverse Device Effects (SADE)

  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.

  24 hours

• Rate of technical success

  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.

  At the end of the procedure

• Description of procedural data : dosimetry

  Dosimetry data during the procedure

  At the end of the procedure

• Description of procedural data : quantity of Embobio

  Quantity of Embobio used for embolization

  At the end of the procedure

• Description of procedural data : time to bleeding control

  Time needed to control the bleeding

  At the end of the procedure

• Description of procedural data : procedure duration

  Total duration of the procedure

  At the end of the procedure

Secondary Outcomes (6)

• Rate of adverse events and adverse device effects

  1 week

• Rate of immediate clinical success

  At the end of the procedure

• Rate of clinical success

  7 days

• Mortality rate

  7 days

• Name and number of the potentiel other devices used to achieve occlusion

  At the end of the procedure

Study Arms (1)

Embobio

EXPERIMENTAL

Patient implanted with Embobio

Device: Embobio

Interventions

Embobio DEVICE

Embolization with the device Embobio

Embobio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Embobio Medical: lead

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hugues Sachot

CONTACT

+33 6 72 336 76 77; hsachot@embobio-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share