Abdomino-pelvic SurgeryEMBOBIO-1NCT07199348
A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding
A study testing Embobio in people with Abdomino-pelvic Surgery and Bleeding, run by Embobio Medical at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdomino-pelvic Surgery, Bleeding, Embolization
- What is being tested?
- Embobio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding: EMBOBIO-1
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).
Read more
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.
Read the 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 treatment. They require fast and effective treatment, as they can be rapidly life-threatening, and that's where embolization steps in.
Embolization is a recent interventional radiology technique whose objective is the occlusion of arterial or venous vessels. Unlike so-called conventional surgical techniques, it is a minimally invasive treatment consisting in endovascular navigation using catheters and microcatheters to reach target vessels where the embolic agent is delivered. The choice of the embolic agent is guided by the indication of the procedure as well as the embolization site. Available permanent embolic agents include calibrated microparticles, metallic implants (coils, plugs) and bioglue. Although the ideal embolic agent does not exist, the choice of material remains a fundamental step in embolization procedures, and the development of new agents is an important avenue of research.
The choice of the embolic agent for bleeding control is based on the site of bleeding, the size of the artery, how fast the bleeding can be controlled but also the time required for embolic agent preparation, its price and the physician's preference. In this indication, the most often used permanent embolic agents are coils. Known adverse device effects of coils are risks of migration, non-target embolization, infection and damage to the wall vessels.
With the urgency of climate change and the demand for natural products in reaction to the overconsumption of chemicals for decades, both food and health industries have experienced a very strong demand for products with a biological process, both respectful of the environment in its design, and of the organism in its distribution. In this context, it seems appealing and important to develop new agents designed from new materials. Indeed, the use of organic materials is a game-changer that is both innovative and promising. More than these aspects, the development of organic embolic material seems necessary to improve the biocompatibility of implantable medical devices with the organism.
To conclude, the best embolic agent for abdominopelvic bleeding should provide a fast and effective long-term occlusion of the bleeding arteries, be safe, prepared speedily, easy to use, cheap and ecofriendly.
Embobio has been designed and developed to meet all these expectations. Embobio is the first organic agent designed for permanent embolization. We demonstrated in a preclinical study that this new agar-agar embolization implant is easy to use and effective in stopping bleeding in a hemorrhagic shock model, making it well-suited for emergency interventional radiology procedures.
- Conditions
- Abdomino-pelvic Surgery, Bleeding, Embolization
- Being tested
- Embobio
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmbobioDevice
Embolization with the device Embobio
| Study group | Role | What they receive |
|---|---|---|
| Embobio | Experimental | Patient implanted with Embobio Receives: Device: Embobio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the end of the procedure
Description of procedural data : dosimetry
Dosimetry data during the procedure
Measured: At the end of the procedure
Description of procedural data : quantity of Embobio
Quantity of Embobio used for embolization
Measured: At the end of the procedure
Description of procedural data : time to bleeding control
Time needed to control the bleeding
Measured: At the end of the procedure
Description of procedural data : procedure duration
Total duration of the procedure
Measured: At the end of the procedure
Secondary outcomes (6)
Rate of adverse events and adverse device effects
The rate of adverse events, serious adverse events and adverse device effects, up to 1 week.
Measured: 1 week
Rate of immediate clinical success
Immediate clinical success will be defined as the successful achievement of embolization, and the absence of extravasation of contrast after arterial embolization at the end of the procedure
Measured: At the end of the procedure
Rate of clinical success
Clinical success will be defined as the absence of rebleeding of target artery(ies) requiring reintervention (repeat embolization or additional surgery) within 7 days.
Measured: 7 days
Mortality rate
Mortality rate related to device use, embolization procedure and pathology at 7 days
Measured: 7 days
Name and number of the potentiel other devices used to achieve occlusion
Name and number of the devices used to achieve occlusion (other than Embobio) and whether their use was anticipated or due to investigational device failure.
Measured: At the end of the procedure
Interventional Radiologist's satisfaction questionnaire
(translated from French) Q1. Did you achieve the expected embolization results?
- Yes
- Partially
- No
Q2. How would you rate the ease of handling Embobio?
- Difficult
- Average
- Easy
- Very easy
Q3. How would you describe the ease of injection?
- Very good
- Good
- Average
- Poor
Q4. How do you find the speed of occlusion?
- Very good
- Good
- Average
- Poor
Q5. How do you find the use of Embobio compared to other agents (coils, particles)?
- More difficult
- Equivalent
- Easier
Measured: At the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start8 Oct 2025
- Primary completion24 Jun 2026
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdomino-pelvic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Embobio Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199348
- Sponsor's protocol ID
- 2025-A00222-47
- Other IDs
- 2025-A00222-47
- Acronym
- EMBOBIO-1
- Status last verified
- Jun 2026
- First submitted
- 19 Sep 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding: EMBOBIO-1
- ClinicalTrials.gov ID
- NCT07199348
- Acronym / sponsor ID
- EMBOBIO-1 / 2025-A00222-47
- Conditions
- Abdomino-pelvic Surgery, Bleeding, Embolization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Embobio MedicalIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 treatment. They require fast and effective treatment, as they can be rapidly life-threatening, and that's where embolization steps in.
Embolization is a recent interventional radiology technique whose objective is the occlusion of arterial or venous vessels. Unlike so-called conventional surgical techniques, it is a minimally invasive treatment consisting in endovascular navigation using catheters and microcatheters to reach target vessels where the embolic agent is delivered. The choice of the embolic agent is guided by the indication of the procedure as well as the embolization site. Available permanent embolic agents include calibrated microparticles, metallic implants (coils, plugs) and bioglue. Although the ideal embolic agent does not exist, the choice of material remains a fundamental step in embolization procedures, and the development of new agents is an important avenue of research.
The choice of the embolic agent for bleeding control is based on the site of bleeding, the size of the artery, how fast the bleeding can be controlled but also the time required for embolic agent preparation, its price and the physician's preference. In this indication, the most often used permanent embolic agents are coils. Known adverse device effects of coils are risks of migration, non-target embolization, infection and damage to the wall vessels.
With the urgency of climate change and the demand for natural products in reaction to the overconsumption of chemicals for decades, both food and health industries have experienced a very strong demand for products with a biological process, both respectful of the environment in its design, and of the organism in its distribution. In this context, it seems appealing and important to develop new agents designed from new materials. Indeed, the use of organic materials is a game-changer that is both innovative and promising. More than these aspects, the development of organic embolic material seems necessary to improve the biocompatibility of implantable medical devices with the organism.
To conclude, the best embolic agent for abdominopelvic bleeding should provide a fast and effective long-term occlusion of the bleeding arteries, be safe, prepared speedily, easy to use, cheap and ecofriendly.
Embobio has been designed and developed to meet all these expectations. Embobio is the first organic agent designed for permanent embolization. We demonstrated in a preclinical study that this new agar-agar embolization implant is easy to use and effective in stopping bleeding in a hemorrhagic shock model, making it well-suited for emergency interventional radiology procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embobio | Experimental | Device: EmbobioPatient implanted with Embobio |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmbobioEmbolization with the device Embobio | Device | Embobio |
Primary outcome
Rate of Serious Adverse Device Effects (SADE)
Time frame: 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
Time frame: 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
Time frame: At the end of the procedure
Dosimetry data during the procedure
Description of procedural data : quantity of Embobio
Time frame: At the end of the procedure
Quantity of Embobio used for embolization
Description of procedural data : time to bleeding control
Time frame: At the end of the procedure
Time needed to control the bleeding
Description of procedural data : procedure duration
Time frame: At the end of the procedure
Total duration of the procedure
6 secondary outcomes
Rate of adverse events and adverse device effects
Time frame: 1 week
Rate of immediate clinical success
Time frame: At the end of the procedure
Rate of clinical success
Time frame: 7 days
Mortality rate
Time frame: 7 days
Name and number of the potentiel other devices used to achieve occlusion
Time frame: At the end of the procedure
Interventional Radiologist's satisfaction questionnaire
Time frame: At the end of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embobio in people with Abdomino-pelvic Surgery and Bleeding, run by Embobio Medical at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Serious Adverse Device Effects (SADE) (time frame: 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.