Using Embrace Hydrogel to stop bleeding in peripheral arteries

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

This study tests if the Embrace Hydrogel can safely stop bleeding in patients with injuries to their peripheral arteries and solid organs.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 118 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Instylla, Inc. (industry)
• Locations: 22 sites (Phoenix, Arizona and 21 other locations)
• Trial ID: NCT05364502 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Embrace Hydrogel Embolic System for treating arterial bleeding in solid organs and peripheral arteries. It is a prospective multicenter, single-arm study that involves patients who are candidates for transarterial catheter embolization. Participants will receive the Embrace HES through a specialized delivery kit and microcatheter, with follow-up evaluations to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with documented arterial bleeding that can be localized via imaging or endoscopy.

Not a fit: Patients with arterial bleeding not suitable for transarterial embolization or those with certain contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management of arterial bleeding, potentially saving lives and reducing complications.

How similar studies have performed: Other studies have shown promise with similar embolization techniques, suggesting potential for success with this novel approach.

Eligibility criteria

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. If known, enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device.

Where this trial is running

Phoenix, Arizona and 21 other locations

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

Study contacts

• Principal investigator: Suvranu Ganguli — Boston Medical Center
• Study coordinator: Clinical Operations

Conditions: Arterial Bleeding in Solid Organs and Peripheral Arteries