(HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial Bleeds
NCT ID: NCT05364502
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
130 participants
INTERVENTIONAL
2022-12-12
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Embrace HES including Instylla™ Delivery Kit and Instylla™ Microcatheter
The Embrace Hydrogel Embolic System (HES) is indicated for embolization of peripheral arterial bleeds in vessels ≤6mm
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Instylla, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Suvranu Ganguli
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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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
Countries
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Other Identifiers
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INY-P-21-002
Identifier Type: -
Identifier Source: org_study_id