Ireland
--:--IST
Starting soon Observational

HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding

NCT07753005 · tracked via the Priya Life Science Japan tracker
Phase
Observational
Started
2026-09-30
Last updated
2026-08-07

Condition(s) studied

HemorrhageGastrointestinal HemorrhageHemoptysisPostpartum Hemorrhage

Investigational drug(s) / intervention(s)

Embolization therapy

Embolization therapy: Embolization of Thoracoabdominal Artery Bleeding (TAB), excluding "Cardiac blood vessels other than Pulmonary artery", "Endoscopic esophageal varices embolization operations", and "Pulmonary artery malformation".

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Primary outcome measure(s)

  • Clinical Success at 1 Month After Histoacryl® Embolization — 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.

Trial sites (11)

FacilityCityRegionStatus
Aichi Cancer Center Hospital Nagoya Aichi-ken
Fujita Health University Hospital Toyoake Aichi-ken
National Cancer Center Hospital East Kashiwa Chiba
Gifu University Hospital Gifu Gifu
Hokkaido University Hospital Sapporo Hokkaido
Hyogo Medical University Hospital Nishinomiya Hyōgo
St. Marianna University Hospital Kawasaki Kawasaki
Nara Medical University Hospital Kashihara Nara
Shizuoka Cancer Center Nagaizumi-chō Shizuoka
National Cancer Center Hospital, Tokyo Tokyo
Teikyo University Hospital Tokyo Tokyo
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 NCT07753005 on ClinicalTrials.gov ↗ ← All trials in Japan