Hydrogel plug could stop dangerous bleeding without surgery
NCT ID NCT05364502
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new gel-like material called Embrace Hydrogel Embolic that doctors inject through a thin tube into bleeding arteries. The gel blocks the bleeding vessel, aiming to stop blood loss without needing surgery or additional devices. The trial involves 130 adults with active arterial bleeding in organs or limbs, and checks if the gel is safe and works well.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients age ≥ 18 years old 2. Subjects who are candidates for transarterial catheter embolization with arterial bleeding documented on a suitable radiologic imaging and/or endoscopic visualization study taken during the index hospitalization that allows for the source of the arterial injury/bleeding to be localized. Includes (but not limited to) the following: 1. Non-variceal Upper Gastrointestinal (UGI) bleeds refractory to endoscopic treatment 2. End organ/visceral bleeds (kidney, liver and spleen including tumor bleeds) 3. Spontaneous hematoma (e.g., rectus sheath and psoas muscle hematomas) 4. Other peripheral arterial bleeds (e.g., pelvic hemorrhage) if not associated with risk of ischemia distal to the lesion or embolization of non-expendable arteries. 3. Subjects with at least one target vessel ≤6mm and Embrace HES can be delivered to the target vessel(s). 4. Subject is willing to comply with follow-up evaluation schedule. 5. No prior embolization in the target territory prior to study entry 6. The subject or a legally authorized representative has provided informed consent approved by the appropriate local IRB/EC. Exclusion Criteria: 1. Life expectancy ≤ 30 days 2. In the Investigator's opinion, due to injury severity the subject is not likely to benefit from angioembolization (e.g., in the presence of significant polytrauma, multiple organ failure or shattered organs). 3. Any contraindication to arteriography or the embolization protocol utilized at treating institution. 4. Pregnant or breast-feeding (women of child-bearing potential must undergo a pregnancy test performed in accordance with local institutional requirements and agree to use contraception for at least six months). 5. Hemorrhagic shock (Class IV-see Appendix 1) at time of treatment 6. Target vascular territory supplied by the pulmonary artery, coronary artery, or cerebral or cerebellar artery (requiring embolization of these arteries) or the artery to be embolized has connections to these arteries via a collateral pathway. 7. Embolization for treatment of spinal arteries, lower GI bleeds, arteriovenous malformations, embolization of arteriovenous shunts, endoleak management, neurovascular bleeds, penetrating trauma of extremities. 8. Forrest Classification Type III UGI bleeds (see Appendix 2) 9. In the investigator's opinion, patient will require embolization of 4 or more discrete vascular territories/arterial injuries (requires that microcatheter be repositioned to discrete area) based on diagnostic angiography or another suitable imaging study. 10. Known or suspected angio-anatomical conditions that in the Investigator's opinion, would prevent the delivery catheter to gain access to the selected position for safe and intended embolization. 11. Known allergies (based on history) to PEG, ferrous compounds, tert Butyl Hydroperoxide, contrast media or procedural sedatives/anesthetics that is not amenable to pre-medication 12. Presence of medically relevant localized or systemic infection 13. The patient has other concurrent conditions or known history that in the opinion of the Investigator would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise patient safety or study objectives (including but not limited to ongoing acute infection, life-threatening concomitant trauma or conditions). 14. Presence of Uncorrectable Coagulopathy: Defined as thrombocytopenia with platelet counts \< 40,000/mm3 and/or INR \> 2.0. 15. If known, enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Banner Health
Phoenix, Arizona, 85006, United States
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Boston Medical Center
Boston, Massachusetts, 02118, United States
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Columbia University Milstein
New York, New York, 10032, United States
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Indiana University
Indianapolis, Indiana, 46902, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Medstar Georgetown University
Washington D.C., District of Columbia, 20007, United States
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Memorial Health Services
Long Beach, California, 92708, United States
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Mount Sinai Hospital
New York, New York, 10029, United States
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Northwestern
Evanston, Illinois, 60611, United States
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Nuvance Health
Danbury, Connecticut, 06810, United States
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Prisma Health
Greenville, South Carolina, 29605, United States
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Stanford University
Stanford, California, 94305, United States
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UCLA Harbor Lindquist Institute
Torrance, California, 90502, United States
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UNC School of Medicine
Chapel Hill, North Carolina, 27599, United States
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University of Cincinnati
Cincinnati, Ohio, 45267, United States
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University of Maryland
Baltimore, Maryland, 21201, United States
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University of Miami
Miami, Florida, 33136, United States
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University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
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Yale University
New Haven, Connecticut, 06520, United States