(HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial Bleeds

Running, not enrolling · Not applicable

Conditions studied: Arterial Bleeding in Solid Organs and Peripheral Arteries

In brief

To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds.

Key facts

Study ID

NCT05364502

Run by

Instylla, Inc.

People needed

130

Starts

2022-12-12

Expected to finish

2026-03-01

Last updated by the study team

2025-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients age ≥ 18 years old
• 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:
• Non-variceal Upper Gastrointestinal (UGI) bleeds refractory to endoscopic treatment
• End organ/visceral bleeds (kidney, liver and spleen including tumor bleeds)
• Spontaneous hematoma (e.g., rectus sheath and psoas muscle hematomas)
• 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.
• Subjects with at least one target vessel ≤6mm and Embrace HES can be delivered to the target vessel(s).
• Subject is willing to comply with follow-up evaluation schedule.
• No prior embolization in the target territory prior to study entry
• The subject or a legally authorized representative has provided informed consent approved by the appropriate local IRB/EC.

You may not qualify if…

• Life expectancy ≤ 30 days
• 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).
• Any contraindication to arteriography or the embolization protocol utilized at treating institution.
• 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).
• Hemorrhagic shock (Class IV-see Appendix 1) at time of treatment
• 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.
• Embolization for treatment of spinal arteries, lower GI bleeds, arteriovenous malformations, embolization of arteriovenous shunts, endoleak management, neurovascular bleeds, penetrating trauma of extremities.
• Forrest Classification Type III UGI bleeds (see Appendix 2)
• 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.
• 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.
• 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
• Presence of medically relevant localized or systemic infection
• 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).
• Presence of Uncorrectable Coagulopathy: Defined as thrombocytopenia with platelet counts < 40,000/mm3 and/or INR > 2.0.
• If known, enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device.

Where it is running

• Banner Health — Phoenix, Arizona, United States
• Memorial Health Services — Long Beach, California, United States
• Stanford University — Stanford, California, United States
• UCLA Harbor Lindquist Institute — Torrance, California, United States
• Nuvance Health — Danbury, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Medstar Georgetown University — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Northwestern — Evanston, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Mount Sinai Hospital — New York, New York, United States
• Columbia University Milstein — New York, New York, United States
• UNC School of Medicine — Chapel Hill, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Prisma Health — Greenville, South Carolina, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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