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(HALT) Embrace Hydrogel Embolic System (HES) Study of Embolization in Peripheral Arterial Bleeds
Sponsor: Instylla, Inc.
Summary
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2022-12-12
Completion Date
2026-03
Last Updated
2025-11-13
Healthy Volunteers
No
Interventions
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
Locations (22)
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