HemorrhageHEALNCT07753005
HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding
An observational study of Hemorrhage and Gastrointestinal Hemorrhage, run by Aesculap AG at 11 sites in Japan.
Trial summary
This observational study will collect information from adult patients in Japan who are treated with Histoacryl® to stop bleeding from arteries in the chest or abdomen, in order to better understand how well the treatment works and how safe it is during routine medical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Gastrointestinal Hemorrhage, Hemoptysis
- What is being tested?
- Embolization therapy
- Type of treatment
- Medical device
- How many people
- 176 participants
- Where
- 11 sitesJapan
- Study dates
- 30 Sep 2026to Jun 2028
- Phase
- Observational
- 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
Study population: Adults with active thoracoabdominal arterial bleeding requiring endovascular embolization will be enrolled at approximately 11 centers in Japan. Eligible patients must be scheduled to undergo embolization with Histoacryl® according to routine clinical practice and within the approved indication in Japan. The study population is expected to include patients with bleeding of various etiologies, including traumatic, iatrogenic, gastrointestinal, pulmonary (hemoptysis), obstetric, neoplastic, or other thoracoabdominal arterial hemorrhages.
Who may be able to join
- Active thoracoabdominal arterial bleeding diagnosed by endoscopy, catheter angiography, or computed tomography angiography (CTA).
- Planned embolization treatment using Histoacryl® as the sole embolic agent for the target lesion.
- No endoleak following thoracic endovascular aortic repair (TEVAR) or endovascular abdominal aortic repair (EVAR).
- Patients with malignant tumors must have an expected survival of at least 1 month.
- Written informed consent obtained from the patient or a legally authorized representative.
Who cannot join
- Previous embolization in the target vascular territory.
- Known allergy or hypersensitivity to n-butyl cyanoacrylate (NBCA), Lipiodol®, or related treatment components.
- Use of adjunctive embolic agents in the same target location.
- Planned surgical treatment after embolization as part of a predefined two-step treatment strategy.
- Severe septicemia.
- Participation in another clinical trial.
Show all 9Show fewer
- Target vessels unsuitable for safe Histoacryl® injection.
- Empiric embolization without identification of a target bleeding location.
- Pregnancy, with the exception of patients treated for postpartum hemorrhage.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Japan11 sites
Gifu University Hospital
Gifu, Gifu, 501-1194
Nara Medical University Hospital
Kashihara, Nara, 634-8522
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
St. Marianna University Hospital
Kawasaki, Kawasaki, 216-8511
Hidefumi Mimura, Dr., +81-44-977-8111, mimura@marianna-u.ac.jp
Shizuoka Cancer Center
Nagaizumi-chō, Shizuoka, 411-8777
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501
Koichiro Yamakado, Dr., +81-798-45-6362, yamakado47@gmail.com
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
National Cancer Center Hospital,
Tokyo, Tokyo, 104-0045
Miyuki Sone, Dr., +81-3-3542-2511, msone@ncc.go.jp
Teikyo University Hospital
Tokyo, Tokyo, 173-8606
Hiroshi Kondo, Dr., +81-3-3964-1211, hkondo0327@gmail.com
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
Masanori Inoue, Dr.
About this study
Official title: Observational, Prospective, Multicenter Study on HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding (TAB)
This observational study will collect information from adult patients in Japan who are treated with Histoacryl® to stop bleeding from arteries in the chest or abdomen, in order to better understand how well the treatment works and how safe it is during routine medical care.
Read the detailed description
TAB includes arterial bleeding of various causes. Untreated bleeding can lead to hemorrhagic shock and organ failure. Transcatheterial arterial embolization is an established treatment option. NBCA is an effective liquid embolizing agent.
- Being tested
- Embolization therapy
- Keywords
- Embolization, Endovascular embolization, Histoacryl, N-butyl cyanoacrylate, NBCA, Hemostasis, Interventional radiology, Thoracoabdominal artery bleeding, Transcatheter arterial embolization, Arterial embolization, Acute arterial hemorrhage, Visceral Aneurysm
- Medical subject headings
- Hemorrhage, Gastrointestinal Hemorrhage, Hemoptysis, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolization therapyDevice
Embolization of Thoracoabdominal Artery Bleeding (TAB), excluding "Cardiac blood vessels other than Pulmonary artery", "Endoscopic esophageal varices embolization operations", and "Pulmonary artery malformation".
| Study group | Role | What they receive |
|---|---|---|
| Embolization | Patients, treated with Histoacryl® for embolization after bleeding Receives: Device: Embolization therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success at 1 Month After Histoacryl® Embolization
Clinical success is defined as absence of bleeding from the target location after embolization with Histoacryl® without need for re-embolization or other re-interventions of the target lesion due to persistent or recurrent hemorrhage. Assessment performed on a per-patient basis.
Measured: 30 ± 10 days after index embolization procedure
Secondary outcomes (14)
Technical Success of Embolarization
Technical success is defined as absence of angiographic evidence of bleeding from the target location at completion of the index embolization procedure. Assessment performed on a per-lesion basis.
Measured: Immediately after completion of the index procedure
Clinical Success at 7 Days
Clinical success defined as absence of bleeding from the target location after embolization without need for re-embolization or other re-interventions due to persistent or recurrent hemorrhage.
Measured: 7 ± 2 days after embolarization
Clinical Success at 3 Months (Optional Follow-up)
Clinical success as defined for the primary endpoint, assessed at optional long-term follow-up.
Measured: 90 ± 15 days after embolization
Successful Device Delivery
Successful delivery is defined as administration of Histoacryl® with intact microcatheter retrieval at the end of the embolization procedure.
Measured: During the index embolization procedure
Immediate Clinical Improvement
Immediate clinical improvement is achieved when at least one unstable baseline parameter (systolic blood pressure, respiratory rate, Glasgow Coma Scale, or diuresis when applicable) improves to a stable level and none deteriorates to an unstable level after the embolization procedure.
Definition of Glasgow Scale (GCS):
is a clinical diagnostic tool widely used since the 1970s to assess a patient's level of consciousness. Initially primarily utilized in patients with traumatic brain injuries, its utilization has extended to assess the level of consciousness. The GCS score takes into consideration three components: eye movements, verbal response (e.g., speech), and motor response (e.g. purposeful body movements).
Measured: Immediately after completion of embolization
Freedom From Serious Adverse Events (SAEs)
Proportion of patients without serious adverse events following embolization.
Measured: 7 days, 30 days, and optional 90 days after embolization
Major Procedure-Related Complications
Occurrence of major relevant procedure-related complications including non-target embolization, allergic reaction, and catheter breakage or entrapment.
Measured: During the index procedure
Ischemic Complications at the Target Location
Occurrence of ischemic complications in the target location following embolization.
Measured: Index procedure through 90 days
Device-Related Serious Adverse Events
Occurrence of serious adverse events considered related to Histoacryl®
Measured: Index procedure through 90 days
All-Cause Mortality
Death from any cause following embolization treatment.
Measured: Up to 90 days after embolization
Bleeding-Related Mortality
Death attributable to the target location bleeding event.
Measured: Up to 90 days after embolization
Surgical Conversion
Need for surgical intervention because of persistent or recurrent bleeding not controlled by embolization.
Measured: During the index hospitalization
Length of Hospital Stay
Duration of hospitalization following the embolization procedure.
Measured: From procedure date until hospital discharge (up to 30 days)
Unplanned Rehospitalization
Occurrence of rehospitalization that was not planned at the time of discharge.
Measured: Up to 30 days after embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Miyuki Sone, Dr., Principal investigator, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753005
- Sponsor's protocol ID
- AAG-O-H-25119
- Acronym
- HEAL
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Multicenter Study on HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding (TAB)
- ClinicalTrials.gov ID
- NCT07753005
- Acronym / sponsor ID
- HEAL / AAG-O-H-25119
- Keywords
- Embolization, Endovascular embolization, Histoacryl, N-butyl cyanoacrylate, NBCA, Hemostasis, Interventional radiology, Thoracoabdominal artery bleeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 7 Aug 2026 (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 observational study will collect information from adult patients in Japan who are treated with Histoacryl® to stop bleeding from arteries in the chest or abdomen, in order to better understand how well the treatment works and how safe it is during routine medical care.
Detailed description
TAB includes arterial bleeding of various causes. Untreated bleeding can lead to hemorrhagic shock and organ failure. Transcatheterial arterial embolization is an established treatment option. NBCA is an effective liquid embolizing agent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization | – | Device: Embolization therapyPatients, treated with Histoacryl® for embolization after bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with active thoracoabdominal arterial bleeding requiring endovascular embolization will be enrolled at approximately 11 centers in Japan. Eligible patients must be scheduled to undergo embolization with Histoacryl® according to routine clinical practice and within the approved indication in Japan. The study population is expected to include patients with bleeding of various etiologies, including traumatic, iatrogenic, gastrointestinal, pulmonary (hemoptysis), obstetric, neoplastic, or other thoracoabdominal arterial hemorrhages.
Key inclusion criteria (5 listed)
- Active thoracoabdominal arterial bleeding diagnosed by endoscopy, catheter angiography, or computed tomography angiography (CTA).
- Planned embolization treatment using Histoacryl® as the sole embolic agent for the target lesion.
- No endoleak following thoracic endovascular aortic repair (TEVAR) or endovascular abdominal aortic repair (EVAR).
- Patients with malignant tumors must have an expected survival of at least 1 month.
- Written informed consent obtained from the patient or a legally authorized representative.
Key exclusion criteria (9 listed)
- Previous embolization in the target vascular territory.
- Known allergy or hypersensitivity to n-butyl cyanoacrylate (NBCA), Lipiodol®, or related treatment components.
- Use of adjunctive embolic agents in the same target location.
- Planned surgical treatment after embolization as part of a predefined two-step treatment strategy.
- Severe septicemia.
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 |
|---|---|---|
| Embolization therapyEmbolization of Thoracoabdominal Artery Bleeding (TAB), excluding "Cardiac blood vessels other than Pulmonary artery", "Endoscopic esophageal varices embolization operations", and "Pulmonary artery malformation". | Device | Embolization |
Primary outcome
Clinical Success at 1 Month After Histoacryl® Embolization
Time frame: 30 ± 10 days after index embolization procedure
Clinical success is defined as absence of bleeding from the target location after embolization with Histoacryl® without need for re-embolization or other re-interventions of the target lesion due to persistent or recurrent hemorrhage. Assessment performed on a per-patient basis.
14 secondary outcomes
Technical Success of Embolarization
Time frame: Immediately after completion of the index procedure
Clinical Success at 7 Days
Time frame: 7 ± 2 days after embolarization
Clinical Success at 3 Months (Optional Follow-up)
Time frame: 90 ± 15 days after embolization
Successful Device Delivery
Time frame: During the index embolization procedure
Immediate Clinical Improvement
Time frame: Immediately after completion of embolization
Freedom From Serious Adverse Events (SAEs)
Time frame: 7 days, 30 days, and optional 90 days after embolization
Major Procedure-Related Complications
Time frame: During the index procedure
Ischemic Complications at the Target Location
Time frame: Index procedure through 90 days
Device-Related Serious Adverse Events
Time frame: Index procedure through 90 days
All-Cause Mortality
Time frame: Up to 90 days after embolization
Bleeding-Related Mortality
Time frame: Up to 90 days after embolization
Surgical Conversion
Time frame: During the index hospitalization
Length of Hospital Stay
Time frame: From procedure date until hospital discharge (up to 30 days)
Unplanned Rehospitalization
Time frame: Up to 30 days after embolization
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 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Miyuki Sone, Dr. principal investigator
National Cancer Center Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Gastrointestinal Hemorrhage, run by Aesculap AG at 11 sites in Japan.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. 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?
Contact Marta Soteras, Dr. (+34 935 8662 ext. 00, studies@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success at 1 Month After Histoacryl® Embolization (time frame: 30 ± 10 days after index embolization procedure). 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 7 Aug 2026.