ACTIVE_NOT_RECRUITING

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

Conditions

Arterial Bleeding in Solid Organs and Peripheral Arteries

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Prospective Multicenter Single-Arm Staged Study to Evaluate the Safety and Effectiveness of Embrace™ Hydrogel Embolic For Transcatheter Embolization of Arterial Bleeding in Solid Organs and Peripheral Arteries

Quick Facts

Study Start:2022-12-12

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05364502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Suvranu Ganguli

PRINCIPAL_INVESTIGATOR

Boston Medical Center

Study Locations (Sites)

Banner Health

Phoenix, Arizona, 85006

United States

Memorial Health Services

Long Beach, California, 92708

United States

Stanford University

Stanford, California, 94305

United States

UCLA Harbor Lindquist Institute

Torrance, California, 90502

United States

Nuvance Health

Danbury, Connecticut, 06810

United States

Yale University

New Haven, Connecticut, 06520

United States

Medstar Georgetown University

Washington D.C., District of Columbia, 20007

United States

University of Miami

Miami, Florida, 33136

United States

Northwestern

Evanston, Illinois, 60611

United States

Indiana University

Indianapolis, Indiana, 46902

United States

University of Maryland

Baltimore, Maryland, 21201

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Boston Medical Center

Boston, Massachusetts, 02118

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Columbia University Milstein

New York, New York, 10032

United States

UNC School of Medicine

Chapel Hill, North Carolina, 27599

United States

University of Cincinnati

Cincinnati, Ohio, 45267

United States

University of Oklahoma

Oklahoma City, Oklahoma, 73104

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Prisma Health

Greenville, South Carolina, 29605

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Instylla, Inc.

Suvranu Ganguli, PRINCIPAL_INVESTIGATOR, Boston Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-12

Study Completion Date2026-03

Study Record Updates

Study Start Date2022-12-12

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Arterial Bleeding in Solid Organs and Peripheral Arteries